AbbVie host shared decision making showcase in Parliament to highlight importance of patients being involved in decisions about their care

Press releases   •   Mar 10, 2020 10:00 GMT

MAIDENHEAD, UK, 10th March, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today hosted a Showcase on Shared Decision Making, which highlighted the importance of patients being involved in decisions made about their care.

The showcase took place just over one year after the launch of the NHS Long Term Plan and Universal Personalised Care Plan which established ambitious targets to put shared decision making at the heart of patient care.

The showcase provided a platform for patient groups, NHS Trusts, and healthcare providers to share their innovative work. With projects from therapy areas such as MS, arthritis, Lymphoma, Autism, Hepatitis C, kidney dialysis and more. All focused on empowering patients to take an active part in decisions about their treatment and care.

The event was attended by Parliamentarians, policy makers and national NHS bodies.

Professor Matthew Cripps, Director of Sustainable Healthcare at NHS England & NHS Improvement who opened the event said, “Chapter one of the NHS Long Term Plan makes personalised care business as usual across the health and care system. At NHS England, we’re working to make this a reality, and shared decision making is a key component of this. This showcase has demonstrated how putting patients at the center of their care has a significant impact on outcomes for patients.”

Todd Manning, UK General Manager, AbbVie stated: “AbbVie is committed to working with key partners across the health and care system, with the aim of ensuring patients are involved in the decisions made about their care. For example, we’ve supported projects to develop patient information and those like the Picker Institute survey on shared decision making in dermatology which identified a lack of patients’ involvementin decisions about their care, as showcased at this year’s Shared Decision Making Showcase. In 2020 we will call for policy reform with an aim to embed shared decision making across the NHS.”

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About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

AbbVie hosts a Showcase on Shared Decision Making, which highlights the importance of patients being involved in decisions made about their care.

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RINVOQ® ▼(upadacitinib) Granted EU Marketing Authorisation for the Treatment of Eligible Adults with Moderate to Severe Active Rheumatoid Arthritis

Press releases   •   Dec 18, 2019 16:20 GMT

  • Marketing authorisation supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis programme evaluating nearly 4,400 patients1-5
  • In five pivotal Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis1-5
  • Upadacitinib offered patients improved rates of clinical remission* or low disease activity** compared to treatment with placebo; methotrexate monotherapy; and adalimumab plus methotrexate 1-5
  • An estimated 400,000 people in the UK are living with rheumatoid arthritis, the majority of whom don’t achieve remission 6,7

MAIDENHEAD, UK, 18 December, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorisation for RINVOQ® (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate (MTX).

“Over the past two decades important advances in the treatment of rheumatoid arthritis have been made, making clinical remission a possibility for more people living with rheumatoid arthritis”, said Alice Butler, UK Medical Director, AbbVie. “We are proud to have been at the forefront of this and to now be able to offer people with moderate to severe RA a new oral treatment option.”

The EC authorisation of upadacitinib was supported by data from the global Phase 3 SELECT rheumatoid arthritis programme, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY.1-5 The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to MTX.1-5

“In the SELECT programme upadacitinib has shown notable consistency in efficacy in clinical trials of patient populations from across the globe”, said Prof Andrew Cope, Head of the Centre for Rheumatic Diseases at King’s College London. “The resuts of these studies mean that patients with active disease have another treatment option with an acceptable safety profile that may induce disease remission even when they have had an inadequate response to drugs such as methotrexate or anti-TNF therapy. Upadacitinib can be used as a single agent and so could benefit many patients who have struggled to tolerate alternative therapies”.

Highlights from the Phase 3 SELECT rheumatoid arthritis programme

Across the SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. Notably, upadacitinib demonstrated consistent efficacy with or without methotrexate and achieved consistent remission* rates across patient populations studied.1-4

Highlights included:

  • In SELECT-COMPARE, upadacitinib plus MTX (n=651) demonstrated significantly higher remission rates* versus placebo plus MTX (n=651) (29 percent vs. 6 percent at week 12; p≤0.001) and HUMIRA® (adalimumab) plus MTX (n=327) (29 percent vs 18 percent at week 12; nominal p≤0.001).4
  • More patients treated with upadacitinib alone (n=217) achieved remission* than MTX (n=216) in SELECT-MONOTHERAPY (28 percent vs 8 percent at week 14; p≤0.0001) and in SELECT-EARLY (48 percent vs 19 percent at week 24; p≤0.001) (n=317 and 314 respectively).3,5
  • In SELECT-EARLY upadacitinib monotherapy (n=317) demonstrated significant inhibition of structural damage***compared to methotrexate (n=314) (0.1 vs 0.7 at week 24; p≤0.01). Upadacitinib +MTX (n=651) also demonstrated significant inhibition of joint damage*** when compared to placebo + MTX (n=651) in SELECT-COMPARE (0.2 vs 0.9 at week 26; p≤0.001).4,5
  • The most commonly reported adverse drug reactions were upper respiratory tract infections (13.5 percent), nausea (3.5 percent), increased blood creatine phosphokinase (2.5 percent) and cough (2.2 percent). The most common serious adverse reactions were serious infections.1-5

More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951).

Earlier this year, upadacitinib received authorisation from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to MTX.

*assessed by DAS28-CRP<2.6 and CDAI≤2.8 

**assessed by DAS28-CRP≤3.2 

*** as measured by modified total Sharp score from baseline

-ENDS-

UK Media:

Natalie Bennett
AbbVie
T: 07818 428074
 natalie.bennett@abbvie.com


Becky Wright
Four Health Communications
T:020 3761 4495
Becky.Wright@fourhealthcommunications.com

 

About upadacitinib in the European Union8

Upadacitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more

disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

Important EU safety information8

Upadacitinib is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Use in combination with other potent Immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥ 75 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunisation guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count < 1000 cells/mm3, absolute lymphocyte count < 500 cells/mm3, or haemoglobin levels < 8 g/dL were reported in <1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care. Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions are upper respiratory tract infections (13.5%), nausea (3.5%), increased blood creatine phosphokinase (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com.

This is not a complete summary of all safety information. See upadacitinib full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About HUMIRA® (adalimumab) in the European Union9

Adalimumab, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.

Important EU safety information9

Adalimumab is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of adalimumab increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with adalimumab. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with adalimumab. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. Please see the full SmPC for complete prescribing information at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information. 

  

References

  1. Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 13.
  2. Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13.
  3. Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. pii: S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
  4. Fleischmann R, et al. Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double&dash;Blind, Randomized Controlled Trial: Arthritis and Rheumatology. 2019. Jul 9; 71 (11):1788-1800
  5. van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
  6. NICE. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375). January 2016
  7. Bergstra SA et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registryAnn Rheum Dis. 2018; 77:1413-1420
  8. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG
  9. HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Accessed November 12, 2019.
     

 About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

UK-UPAD-190114

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AbbVie Presents New Long-Term Data From VENCLYXTO®▼ (venetoclax) Chemotherapy-Free Combination Regimen in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Press releases   •   Dec 09, 2019 17:26 GMT

  • Four-year updated analysis from the MURANO trial showed an 81% reduction in the risk of disease progression or death in patients treated with venetoclax plus rituximab (VenR) and higher rates of undetectable minimal residual disease (uMRD) compared to bendamustine plus rituximab(BR)1
  • Sustained overall survival (OS) benefit was demonstrated with VenR over BR (with a hazard ratio of 0.41), despite 79% of patients in the BR arm who went on to receive a novel targeted treatment. Median OS was not reached for either treatment group1
  • 68% of the 130 patients who completed the treatment course were free of disease progression and maintained OS benefit 24 months after being off venetoclax therapy1
  • Full results are being highlighted today in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition

MAIDENHEAD,UK, December 8, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented long-term data from a post-hoc analysis further supporting the clinical benefit of a fixed treatment duration with venetoclax in combination with rituximab (VenR) in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) compared with a standard of care regimen of bendamustine plus rituximab (BR). The updated data from the Phase 3 MURANO trial four-year analysis (median follow-up of 48 months with all patients off venetoclax treatment for a median of 22 months) showed that patients with R/R CLL who completed the chemotherapy-free combination regimen of venetoclax plus rituximab with a two year fixed treatment duration maintained progression-free survival (PFS) and overall survival (OS) compared to BR.1

Patients who completed treatment with the venetoclax combination also achieved higher rates of uMRD and complete remissions compared to those treated with bendamustine plus rituximab.1 uMRD is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. The full results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition (abstract h#355).

“These results support the benefits of a fixed duration of treatment with venetoclax and rituximab to reduce the risk of disease progression or death in patients with chronic lymphocytic leukemia,” said Mohammed Zaki, M.D., Ph.D., vice president, global head of hematology development at AbbVie. “We remain committed to understanding the full utility of venetoclax combinations.”

“In the four-year analysis from the MURANO trial, treatment with the venetoclax combination resulted in an 81 percent reduction in the risk of progression or death compared to the standard of care,” said Professor John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and director of the Department of Hematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Australia. “The sustained efficacy and manageable safety profile observed in the study further support the clinical benefits of fixed treatment in patients with relapsed or refractory chronic lymphocytic leukemia.”

In the post-hoc analysis, median follow-up for patients who completed two years of treatment with venetoclax plus rituximab without progressive disease (n=130) was 22 months (range: 1 to 35 months). PFS (HR, 0.19, 95% CI: 0.14, 0.25, descriptive p<0.0001) and OS (HR 0.41, 95% CI: 0.26, 0.65, descriptive p<0.0001) was sustained for patients taking VenR compared to those taking BR. 24 months after patients were off therapy, the investigator (INV)-assessed estimated PFS was 68.0% (95% CI 57.6, 78.4). Additionally, the four year OS was 85.3% (95% CI: 89.2, 99.0) in the venetoclax arm compared to 66.8% for BR (medians not reached). Improvements in both PFS and OS were observed in the VenR arm despite 79% of patients in the control arm receiving an additional targeted CLL treatment after disease progression.1

By the end of treatment, 64% of patients had achieved uMRD, and 87% of those patients remained free of disease progression two years post-treatment.1 Achieving uMRD was assessed as a secondary endpoint because it is associated with improved clinical outcomes.2 Higher rates of uMRD were observed off treatment in patients taking VenR than in those taking standard of care BR.1

The safety profile of the combination is consistent with the known safety profile of each individual therapy alone. There were no new serious safety issues observed in the MURANO study since the last update. Excluding non-melanoma skin cancer, there was one report of melanoma in the standard of care cohort, and one report of melanoma and one report of breast cancer in the venetoclax combination cohort.1

Venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of Roche Group, in the U.S. and by AbbVie outside the U.S.

- Ends -

For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com

AbbVie UK Media: 

Joanna Jones 

07795590344

Joanna.jones@abbvie.com


Francesca Morley

07795360167

Francesca.Morley@virgohealth.com

Notes to editors

Design and Results of MURANO Phase 3 Trial

A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized Phase 3 MURANO trial. The trial was designed to evaluate the efficacy and safety of venetoclax in combination with rituximab (N=194) compared with bendamustine in combination with rituximab (N=195). The median age of patients in the trial was 65 years (range: 22 to 85).3

The primary efficacy endpoint was INV-assessed PFS. At the time of the primary analysis, median PFS with venetoclax in combination with rituximab was not reached compared with 17.0 months for bendamustine in combination with rituximab (HR: 0.17; 95% CI: 0.11, 0.25; p<0.0001). In the primary efficacy analysis, the median follow-up for PFS was 23.8 months (range: 0 to 37.4). Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), OS and rates of MRD-negativity.3

About venetoclax

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis.

Venetoclax is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

In January 2019, venetoclax in combination with rituximab was recommended by NICE (The National Institute for Health and Care Excellence) for the treatment of relapsed/refractory CLL on the NHS. Following this, VenR was accepted by the SMC (Scottish Medicines Consortium) for use by the NHS in Scotland in August 2019. These decisions were based on the pivotal results from the Phase 3 MURANO clinical trial. It is the first 24-month fixed treatment duration, chemotherapy-free combination approved for use in this patient population.4

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types. For more information, please visit www.abbvie.co.uk/our-science/therapeutic-focus- areas/Oncology.html

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

References

1. Seymour JF, et al. Four-Year Analysis of Murano Study Confirms Sustained Benefit of Time-Limited Venetoclax- Rituximab (VenR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL). Presented at the 2019 American Society of Hematology Annual Meeting & Exposition: December 8, 2019; Orlando.

2. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018;806398.

3. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.

4. National Institute for Health and Care Excellence. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. 2019. Available at: https://www.nice.org.uk/guidance/ta561/chapter/1-Recommendations

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AbbVie UK Announces Collaboration With NorthWest EHealth to Generate Real World Evidence to Drive Improvements in Patient Care

Press releases   •   Nov 27, 2019 09:00 GMT

  • AbbVie and NorthWest EHealth intend to explore the underlying associations between autoimmune conditions, using technology to interrogate data from NHS general practices
  • Greater Manchester’s population makes the region the ideal location to conduct the work
  • This project is an example of the partnership approach envisaged by the UK Government’s Life Sciences Industrial Strategy, which stresses the importance of collaboration to generate real-world data

MAIDENHEAD, UK, 27 November, 2019 – AbbVie, a research-based global biopharmaceutical company, together with NorthWest EHealth, a world leader in the innovative and trustworthy use of routinely collected healthcare data for clinical evaluation, today announces their partnership to explore the underlying associations between autoimmune conditions.

The collaboration between AbbVie’s UK business and North West EHealth will harness NorthWest EHealth’s proprietary FARSITE software, a cohort finding tool that utilises primary care data.

The North West is an ideal region for this type of investment due to Greater Manchester’s diverse population and its open approach to collaboration with industry, as reflected by the Memorandum of Understanding between the Association of the British Pharmaceutical Industry and the Greater Manchester Combined Authority. It is a prime example of the collaboration approach recommended by the UK Government’s Life Sciences Industrial Strategy.

Alice Butler, AbbVie UK Medical Director commented: “Harnessing the power of NHS data sets offers a significant opportunity to expand our collective knowledge of disease and ultimately work together to raise standards of care. We hope that the partnership model we have developed with NorthWest EHealth could serve as a best practice exemplar for future industry-NHS collaborations.”

Julie Millar, Head of Community Services, NorthWest EHealth, added: “We are delighted to collaborate with AbbVie. Using our FARSITE tool and expertise in interrogating health records, we hope to provide a valuable contribution to advancing scientific understanding of the associations between autoimmune conditions.”

-ENDS-

UK media contacts:

Sarah Beck

+44(0)7818 428111

sarah.beck@abbvie.com

Notes to editors:

About North West EHealth

NorthWest EHealth provides technology to enable regulatory standard real world, data enabled, trials for the life sciences industry. The UK is uniquely placed to perform these types of study due to our single payer system and patient level identifiers which enables linking of the entire longitudinal care records. NorthWest EHealth has developed its own suite of applications and a real-world trial platform (validated to regulatory standard and aligned with FDA framework for real world evidence). These technologies facilitate rapid feasibility, recruitment and delivery of real-world trial study data using linked electronic health resources for consented patients. These technologies are scalable across all coded data sources. The technologies have been designed to operate to international data standards. For more information about NorthWest EHealth, visit www.nweh.co.uk. Follow @NWEHealth on Twitter.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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AbbVie’s SKYRIZI™▼(risankizumab) accepted for use within NHS Scotland

Press releases   •   Oct 07, 2019 17:16 BST

– Positive SMC Detailed Advice Document (DAD)1 for SKYRIZI™ (risankizumab)

- Adult patients in Scotland with plaque psoriasis who have failed, are intolerant to, or contraindicated to conventional systemic therapies, will have NHS access to treatment with high rate of skin clearance at 16 weeks that is maintained through to one year (52 weeks)2

SMC recommendation based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis2-5

– Plaque psoriasis is a chronic condition affecting an estimated 100,000 people in Scotland

and many patients still do not reach treatment goals or lose treatment response over time6,7,8

MAIDENHEAD, UK, 7 October, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Scottish Medicines Consortium (SMC) has published a positive Detailed Advice Document (DAD), confirming that SKYRIZI™▼(risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patientswho have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments.1

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

In clinical studies, risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).2

Psoriasis is a chronic skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. These patches normally appear on the elbows, knees, scalp and lower back, but can appear anywhere on the body9. Psoriasis affects around 1.5-3 percent of people in Scotland8.

Helen McAteer, Chief Executive of The Psoriasis Association, said: “Psoriasis is a difficult to treat, lifelong condition that can affect all parts of an individual’s life. Although there have been advancements in therapy, there are always individuals who find existing treatments either do not work or begin to fail. With the availability of risankizumab within NHS Scotland, patients will now have access to another treatment option that could lead to an improved quality of life, allowing them to experience a life that is not impacted or restricted by the impact of the physical and mental aspects of psoriasis.”

Professor David Burden, Consultant Dermatologist, University of Glasgow, said: “The SMC’s recommendation to offer routine NHS access to risankizumab gives clinicians a new treatment option in the management of moderate to severe psoriasis. The mode of action involves inhibition of the p19 subunit of the IL-23 cytokine, which is known to be important in the pathogenesis of psoriasis. Risankizumab addresses a remaining unmet need for people with moderate to severe psoriasis by enhancing our ability to achieve high levels of lasting skin clearance with a 12-weekly injection.”

The SMC DAD is based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.2-5 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.2-5

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.5 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.5

Alice Butler, AbbVie UK Medical Director commented, “AbbVie is committed to developing and delivering therapeutic options in psoriasis, an area where there is high unmet need. We have worked closely with the SMC to bring risankizumab to patients in Scotland as quickly as possible.”

The European Commission granted Marketing Authorisation for risankizumab on 26 April 2019.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information5

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-ENDS-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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SKYRIZI™▼(risankizumab) Receives NICE Positive Technology Appraisal Guidance for the Treatment of Plaque Psoriasis in Adults

Press releases   •   Aug 21, 2019 09:19 BST

MAIDENHEAD, UK, 21 August 2019 - AbbVie (NYSE: ABBV), a research-based biopharmaceutical company, announces that eligible patients in England and Wales with plaque psoriasis who have failed conventional systemic therapies will have access to SKYRIZI™▼(risankizumab) following the issuing by the National Institute for Health and Care Excellence (NICE) of the Technology Appraisal Guidance (TAG) recommending the treatment1.

The TAG represents the completion of the final step of NICE assessment and follows a positive recommendation by NICE through its Fast Track Appraisal process, which has an accelerated timeframe of 30 days for implementation rather than the usual 90 days associated with a Single Technology Appraisal.

Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time2-4. In clinical studies risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).5

This announcement means that risankizumab will be made available to eligible patients almost two months earlier than would have been the case via other NICE assessment routes.

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information6

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-Ends-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

1 The Technology Appraisal Guidance (TAG) can be accessed via the NICE website

2 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019

3 Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10

4 National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed August 2019)

5 Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30

6 SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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New chemotherapy-free combination treatment VENCLYXTO®▼(venetoclax) plus rituximab accepted for use on the NHS in Scotland for people with previously treated Chronic Lymphocytic Leukaemia

Press releases   •   Aug 12, 2019 14:31 BST

  • For the first time, people in Scotland with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a new chemotherapy-free option with a fixed treatment duration of 24 months.1
  • SMC acceptance is based on the MURANO phase 3 clinical trial, in which venetoclax plus rituximab (VenR) reduced the risk of disease progression or death by eighty-three percent compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).1
  • CLL is the most common form of adult leukaemia with over 3,500 people diagnosed every year in the UK.2,3

MAIDENHEAD, UK, 12th August 2019 – AbbVie (NYSE: ABBV) announced today that NHS patients in Scotland with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL) who have received at least one prior therapy will now have access to venetoclax plus rituximab, a new chemotherapy-free option with a fixed treatment duration of 24 months. The Scottish Medicines Consortium’s (SMC’s) acceptance follows The National Institute for Health and Care Excellence (NICE) recommendation for the combination therapy to be made available on the NHS in England and Wales on 18th January 2019.4

CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,5 Over 3,500 people are diagnosed with CLL in the UK each year.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur.6

Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care said: “We’re delighted the SMC has decided to make the venetoclax plus rituximab combination treatment available in Scotland on the NHS to people living with relapsed or refractory CLL. This decision has the potential to change outcomes in an area where we have seen few clinical advances until recently. Hearing your disease has relapsed or become refractory can be overwhelming for patients and their families, so the SMC’s decision to make available an effective chemotherapy-free option with a fixed treatment duration is very much welcomed by the patient community.”

The SMC’s positive Final Advice is based on results from the pivotal phase 3 MURANO clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared to a standard of care chemoimmunotherapy regimen of bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature).1

Dr Mike Leach, Consultant Haematologist at the Beatson West of Scotland Cancer Centre in Glasgow, said: “The SMC’s approval of venetoclax plus rituximab for the second line treatment of CLL is a significant step forward for patients in Scotland. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. It is capable of achieving deep levels of response with a fixed duration of therapy and allows treatment free periods for our CLL patients.”

In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-), was a secondary endpoint. Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.7 At the nine-month time point, sixty-two percent (n=121/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus thirteen percent (n=26/195) who received bendamustine plus rituximab.1

Recent post treatment follow-up data has provided evidence on long-term outcomes for venetoclax in combination with rituximab. Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively.8

Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to developing and delivering breakthrough therapeutic options in CLL, an area where there is high unmet need and where there are few treatments available. We have worked closely with the SMC to bring venetoclax plus rituximab to patients in Scotland as quickly as possible. This is a very positive outcome for Scottish patients and today’s decision will motivate us further in our ongoing drive to improve patient outcomes in blood cancer.”

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

- Ends -

The final SMC guidance can be accessed via the SMC website.

For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com

For further information:

AbbVie UK Media:

Joanna Jones 

07795590344

Joanna.jones@abbvie.co

Francesca Morley

07795360167

Francesca.Morley@virgohealth.com

Notes to editors

About venetoclax

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.9 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.9

In the MURANO phase 3 clinical trial, the most common adverse event of any grade in both the treatment and control groups was neutropenia (60.8% of the patients in the venetoclax–rituximab group and 44.1% of the patients in the bendamustine–rituximab group). The incidence of serious adverse events was similar in the two groups.1

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

References

1 Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.

2 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: July 2019

3 Cancer Research UK. Chronic lymphocytic leukaemia (CLL): Risks and causes. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/risks-causes Accessed: July 2019

NICE. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/Guidance/TA561. Accessed: July 2019

5 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: July 2019

National Cancer Institute. Living as a Chronic Lymphocytic Leukemia Survivor. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/after-treatment/follow-up.html. Accessed: July 2019.

7 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018; 131(25):2745-2760

8 Seymour J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.

9 Venclyxto Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/32650. Accessed: July 2019

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Results From SKYRIZI™ ▼ (risankizumab) Phase 3 Study in Moderate to Severe Plaque Psoriasis Published in The Lancet

Press releases   •   Jul 24, 2019 14:33 BST

  • In the IMMvent study, 72 percent and 84 percent of patients treated with SKYRIZI™ (risankizumab) achieved PASI 90 and sPGA 0/1, respectively, at week 16 [i]

Maidenhead, UK, 24 July 2019 — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the publication of positive results from the pivotal Phase 3 IMMvent clinical study in The Lancet. The study evaluates the safety and efficacy of SKYRIZI™ (risankizumab) up to 44 weeks compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis.1 Risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (0/1) versus adalimumab at weeks 16 and 44 (p<0.0001).1

“By achieving high levels of skin clearance through to week 44, risankizumab demonstrated the ability to make a positive, lasting impact on all the signs and symptoms of psoriasis,” said Dr Anthony Bewley, Consultant Dermatologist, Barts Health NHS Trust, London. “I am really pleased to see that my patients stand to benefit from the positive IMMvent study results about risankizumab that appeared recently in The Lancet.”

At week 16, 72 percent of patients receiving risankizumab (n=301) at the label dose achieved PASI 90 compared to 47 percent of patients treated with adalimumab (n=304) at the label dose.1 84 percent of risankizumab-treated patients achieved a sPGA score of clear or almost clear (0/1) compared to 60 percent of patients receiving adalimumab.1 Additionally, 40 percent and 41 percent of patients treated with risankizumab achieved complete skin clearance (defined as PASI 100 and sPGA 0, respectively) at week 16 compared to 23 percent of patients treated with adalimumab (for both measures of skin clearance).1

In the second phase (week 16 to week 44) of IMMvent, patients receiving adalimumab who achieved a response of at least PASI 50 but less than PASI 90 at week 16 (intermediate responders*) were re-randomised to either switch to risankizumab (n=53) or continue adalimumab (n=56).1 Of these patients, those re-randomised to risankizumab saw significantly greater response rates.1 66 percent achieved PASI 90 at week 44 when switched to risankizumab, compared to 21 percent of patients who continued on adalimumab (p<0.001).1 Additionally, 40 percent of patients who switched to risankizumab achieved complete skin clearance (PASI 100 or sPGA 0) at week 44 compared to 7 percent of patients who continued treatment with adalimumab (for both measures of skin clearance). All the patients who switched to risankizumab at week 16 started at the initial label dose schedule.1

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

“Publication of these positive results in The Lancet marks another important milestone demonstrating the potential of risankizumab to be an important treatment option that is now available in our dermatology portfolio,” said Dr Alice Butler, UK Medical Director, AbbVie.

IMMvent Efficacy Results1**
Week 16 (all patients) Week 44 (intermediate responders group)*
Risankizumab (n=301) Adalimumab (n=304) Adalimumab/ risankizumab (n=53) Adalimumab/ adalimumab (n=56)
PASI 90 72% 47% 66% 21%
sPGA 0/1 84% 60% 74% 34%
PASI 100 40% 23% 40% 7%
sPGA 0 41% 23% 40% 7%
*Intermediate responders are defined as patients who achieved at least PASI 50 but less than PASI 90 at week 16.**All primary and ranked secondary endpoints achieved p-values of <0.0001.

The study also showed patients treated with risankizumab self-reported an improved quality of life. At week 16, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had an impact on their health-related life quality, compared to adalimumab.[ii] Risankizumab-treated patients maintained reported outcomes at week 44.2

In the study, no new safety findings were observed in patients receiving continuous risankizumab or in those switched from adalimumab to risankizumab.1 There was no increase in adverse events in patients re-randomised from adalimumab to risankizumab.1 Serious adverse events occurred in 3 percent of patients treated with both risankizumab and adalimumab.1 The most frequently reported adverse events for both risankizumab and adalimumab were viral upper respiratory tract infection, upper respiratory tract infection and headache.1

About the Phase 3 IMMvent study1

The IMMvent study is a Phase 3 randomised, double-blind, active-controlled study designed to evaluate the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit and is approved in the EU for adults living with moderate to severe psoriasis who are candidates for systemic treatment.3

In the first phase, patients were randomised 1:1 to either risankizumab (150 mg) or adalimumab (80 mg initial dose followed by 40 mg one week later and every other week thereafter) as a subcutaneous injection. Patients originally randomised to risankizumab received it throughout the study given at baseline, week 4, week 16, week 28 and week 40. Those originally randomised to adalimumab followed a treatment course based on week 16 response: those with less than PASI 50 at week 16 switched to risankizumab; those with PASI 90 continued adalimumab; and those with a PASI 50 but less than PASI 90 response were re-randomised to switch to risankizumab or continue adalimumab. Any patient re-randomised from adalimumab to risankizumab at week 16 received it at week 16, week 20, week 32 and week 44. Results from the study showed risankizumab achieved all primary and ranked secondary endpoints.More information on this trial can be found at www.clinicaltrials.gov (NCT02694523).

About risankizumab in the European Union3

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information[iii]

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

About adalimumab in the European Union[iv]

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Important EU Safety Information4

Adalimumab is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of adalimumab increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukaemia have been reported in patients treated with adalimumab. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with adalimumab. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. See SKYRIZI (risankizumab) and HUMIRA (adalimumab) full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc. Globally, prescribing information varies; refer to the individual country product label for complete information.


[i]
Reich, K., Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a Randomized, Double-blind, Active-comparator, Controlled Phase 3 Trial (IMMvent). The Lancet. 2019.

[ii] Crowley, J., et al. ePoster #P1947. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.

[iii] SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.

[iv] HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated October 5, 2017. Accessed June, 2019.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

AbbVie Appoints New General Manager in U.K.

Press releases   •   Jul 19, 2019 13:03 BST

Maidenhead, UK, 19th July 2019 – AbbVie, a global biopharmaceutical company, today announced that Todd Manning has been named General Manager, AbbVie U.K. This change will be effective 1st September 2019.

Todd moves to the UK from his current position within the company as General Manager, AbbVie Ireland. Elected to the Irish Pharmaceutical Healthcare Association (IPHA) strategy board in 2016 and to the Board of Directors in 2018, he has held the positions of Deputy Vice President and Chair of the Finance Committee. He also served on several working groups including Market Access and Biotherapeutics.

Since joining Abbott in 2004 he has held roles of increasing responsibility; Director, Immunology, Ireland; Director, Immunology, Canada; HCV Senior Commercial Director, Western Europe & Canada. Prior to joining the organisation, Todd was with TAP Pharmaceuticals, Inc. where he held a variety of commercial sales and marketing positions.

Todd earned a Bachelor’s degree in Chemistry from the College of Holy Cross in Massachusetts.

Todd will succeed Jérôme Bouyer, UK General Manager since July 2017, who is appointed Vice President, AbbVie Eastern Europe Middle East and Africa (EEMEA).

###

Media:

Gwenan White, Communications Director AbbVie U.K.

+44 787 6391 429

gwenan.white@abbvie.com 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Todd Manning has been named General Manager, AbbVie U.K. This change will be effective 1st September 2019. Todd moves to the UK from his current position within the company as General Manager, AbbVie Ireland.

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NICE Issues Positive Final Appraisal Document for SKYRIZI™▼(risankizumab) for the Treatment of Plaque Psoriasis in Adults

Press releases   •   Jul 12, 2019 10:16 BST

– Positive NICE Final Appraisal Document (FAD) for SKYRIZI™ (risankizumab), a humanised immunoglobulin G1 (IgG1) monoclonal antibody, means that adult patients in England and Wales with plaque psoriasis, who have failed conventional systemic therapies, will have NHS access to treatment with high rate of skin clearance at 16 weeks that is maintained through to one year (52 weeks)1

- Risankizumab has been reviewed by NICE through its Fast Track Appraisal process, meaning that NHS England/commissioners have committed to providing funding for risankizumab within 30 days of final guidance publication (expected 21 August 2019)

NICE FAD based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis1-4

– Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time5-6,7

MAIDENHEAD, UK, 12 July, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD), confirming that SKYRIZI™▼(risankizumab) is recommended for the treatment of severe psoriasis in adult patientswho have failed conventional systemic therapies.8

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

In clinical studies, risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).1

Helen McAteer, Chief Executive of The Psoriasis Association, said: “The positive guidance from NICE is a welcome step change for people in England and Wales with severe psoriasis as it means they will be able to access a treatment option on the NHS that offers maintenance dosing of 12-week injections over those dosed more frequently, and good PASI90 and PASI100 clearance data. We know that these things are important to patients.”

Psoriasis is a chronic skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. These patches normally appear on the elbows, knees, scalp and lower back, but can appear anywhere on the body9. Psoriasis affects around 1.75 percent of people in the UK7.

Professor Richard Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust, said: “NICE’s recommendation to offer routine NHS access to risankizumab gives clinicians a new treatment option in the management of severe psoriasis. The mode of action of risankizumab, which inhibits the p19 subunit of IL-23 cytokine, thought to drive psoriasis pathogenesis, addresses significant remaining unmet need and enhances our ability to achieve high levels of skin clearance for people with severe psoriasis.”

The NICE FAD is based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.1-4 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.1-4

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.4 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.4

"AbbVie is committed to developing life-changing medicines. Ensuring rapid access to such medicines is a critical part of that commitment and we have worked closely with NICE for risankizumab to be considered through the Fast Track Appraisal process. Risankizumab’s availability on the NHS will represent the fastest time between marketing authorisation and reimbursement of any biologic treatment for psoriasis,” said Dr Alice Butler, UK Medical Director, AbbVie.

The European Commission granted Marketing Authorisation for risankizumab on 26 April 2019.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information4

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-ENDS-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

  • 1.Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
  • 2.Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
  • 3.Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
  • 4.SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc
  • 5.International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
  • 6.Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  • 7.National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed July 2019)
  • 8.National Institute for Health and Care Excellence, Fast Track Appraisal: Risankizumab for treating moderate to severe plaque psoriasis (ID1398), available at https://www.nice.org.uk/guidance/indevelopment/gid-ta10349 (accessed July 2019)
  • 9.NHS, psoriasis overview, available at https://www.nhs.uk/conditions/psoriasis/ (accessed July 2019)

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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Contacts 5 contacts

For general press enquiries please contact the AbbVie Corporate Communications team at UKMediaRelations@abbvie.com or call us on 01628 925200

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About AbbVie UK

We're a company that takes on the toughest health challenges.

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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