SKYRIZI™ ▼(risankizumab) Granted EU Marketing Authorisation for the Treatment of Moderate to Severe Plaque Psoriasis in Adults

Press releases   •   Apr 30, 2019 13:14 BST

– Authorisation based on results from clinical studies showing high rates of skin clearance at 16 weeks; this clearance was also observed at one year with every 12-week maintenance dosing1-4

– Risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit, offers moderate to severe psoriasis patients a new therapeutic option5

– Psoriasis is a chronic condition affecting 125 million people worldwide and many patients still do not reach treatment goals or lose treatment response over time6-8

MAIDENHEAD, UK, 30 April, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has granted a Marketing Authorisation to SKYRIZI™ ▼(risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. The recommended dose of risankizumab is 150mg (two 75 mg injections) administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 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).1-4

"This authorisation is an important step forward in providing people living with moderate to severe psoriasis across the UK with a new treatment option,” said Alice Butler, UK Medical Director, AbbVie. “We know that patients who achieve and then maintain high skin clearance of PASI90 or complete skin clearance of PASI100 have significantly better health related quality of life outcomes than those with lower levels of skin clearance of PASI75-89.12”

Professor Christopher Griffiths, University of Manchester, said: “The introduction of risankizumab is good news for those people in the UK who have moderate to severe psoriasis. The options now available for dermatologists treating this severity of psoriasis have never been better. Indeed, we are in the enviable position of being able to offer the majority of such patients complete or almost complete clearance of the signs and symptoms of psoriasis, at least in the short term. This progress could not have been achieved without a detailed understanding of the immune drivers of psoriasis and the identification of new targets for drugs such as risankizumab.”

Helen McAteer, Chief Executive of the Psoriasis Association, said: “We are delighted that risankizumab has received licensed authorisation following the successful Phase III trials. Patients in touch with the Psoriasis Association have reported a preference for every 12 week injections over those dosed more frequently and the long-term PASI90 and PASI100 clearance data will be welcomed by people living with moderate–severe psoriasis.”

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

Highlights from the pivotal Phase 3 programme

  • In the UltIMMa-1 (n=506) and UltIMMa-2 studies (n=491), risankizumab met the co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 vs placebo (p<0.0001).1,4 After 16 weeks of treatment, 88 percent (UltIMMa-1) and 84 percent (UltIMMa-2) of risankizumab patients (UltIMMa-1 n=304; and UltIMMa-2 n=294) achieved sPGA 0/1 and 75 percent of patients receiving risankizumab in both studies achieved PASI 90.1,4
  • An integrated analysis of patients who received risankizumab in the UltIMMa-1 and UltIMMa-2 studies (n=598) showed that of patients who achieved PASI 90 with risankizumab at week 16, 88 percent of these patients maintained PASI 90 with risankizumab through to one year (52 weeks) (p=0.0009).1
  • Risankizumab demonstrated superiority versus adalimumab in the IMMvent study (n=605), with 72 percent of rizankizumab patient (n=301) achieving PASI 90 compared to 47 percent of patients treated with adalimumab (n=304) at week 16 (p<0.001).2,4 Patients achieving PASI 50-<90 after 16 weeks of adalimumab treatment were re-randomised at week 16, following this 66 percent of patients who started on adalimumab and switched to risankizumab (n=53) achieved PASI 90, compared to 21 percent who continued on adalimumab (n=56) at week 44 (p<0.001).2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 were met (p<0.001).2,4
  • Results from IMMhance (n=507) showed that, among people receiving risankizumab (n=407) who achieved clear or almost clear skin (sPGA 0/1) response at week 28 and were re-randomised to continue risankizumab (n=111), 87 percent maintained this response at week 52 compared to 61 percent re-randomized to withdraw (n=225).9 The co-primary endpoints of sPGA 0/1 at week 16 and week 52 were met (p<0.001).3,4
  • Risankizumab was also reported to improve health-related quality of life in Phase 3 studies. In UltIMMa-1 and UltIMMa-2, significantly more patients treated with risankizumab self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 (75 percent in UltIMMa-1 and 71 percent in UltIMMa-2) compared with ustekinumab (47 percent in UltIMMa-1 and 44 percent in UltIMMa-2) at one year (p<0.0001).1,4 DLQI is a measure of a patient's health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality.10
  • More information about this programme can be found on www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

    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

    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.

    About adalimumab in the UK

    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 Information11

    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 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.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    Full summary of product characteristics is available at: https://www.medicines.org.uk/emc

    ###

    UK Media:

    Sarah Beck

    +44 7818 428 111

    Sarah.beck@abbvie.com

    References:

    1.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.

    2.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.

    3.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.

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

    5.Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.

    6.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.

    7.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.

    8.Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.

    9.Langley, et al. Efficacy and Safety of Continuous Q12W Risankizumab versus Treatment Withdrawal: Results from the Phase 3 IMMhance Trial. Poster #10093. 2019 American Academy of Dermatology Annual Meeting. 2019.

    10.Hongbo Y, et al. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64.

    11.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 March 22, 2019.

    12.Ryan C et al. Poster ID P2002. European Academy of Dermatology and Venerology. 12–16th September 2018, Paris, France

    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 STATEMENT ON NHS ENGLAND CONTRACT AWARD IN HEPATITIS C ELIMINATION TENDER

    Press releases   •   Apr 30, 2019 00:01 BST

    EMBARGOED UNTIL 00.01 TUESDAY 30 APRIL

    MAIDENHEAD, UK, 30 April, 2019 –AbbVie welcomes the award of a contract by NHS England to continue working in partnership to facilitate the identification and treatment of hepatitis C (HCV) patients in England. This is an important step towards bringing closer the goal of NHS England (NHSE) to eliminate hepatitis C in England by 2025.

    “Our aim to bring well-tolerated, highly effective and curative treatments to patients that need them, and to eliminate this chronic disease as a burden to the healthcare system, is today closer to being achieved,” said Joette Gdovin PhD, Head of UK Market Access, AbbVie UK. “We have worked closely with NHS England to build an HCV elimination strategy and we appreciate that the NHSE tender model will ensure availability of all suitable treatments in England.”

    -ENDS-

    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 Receives CHMP Positive Opinion for SKYRIZI™ ▼ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis in adults

    Press releases   •   Mar 01, 2019 12:13 GMT

    CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission1-3

    –In Phase 3 trials, risankizumab achieved significantly greater response of clear or almost clear skin (sPGA 0/1 and PASI 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 with every 12-week dosing after initial start dosing1-3

    –Risankizumab (under the trade name SKYRIZI) is an investigational, humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit4


    NORTH CHICAGO, Ill., March 1, 2019– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI™ (risankizumab , an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patientswho are candidates for systemic therapy.

    The CHMP positive opinion is supported by data from the global Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies.1-3 Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, all co-primary and ranked secondary endpoints were met, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 (depending on study design).1-3 The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.5 Most reported adverse reactions were mild or moderate in severity.5

    "Plaque psoriasis can have a significant physical, psychological and social burden on people living with the condition,” said Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited that the CHMP has recognized risankizumab’s potential to significantly reduce the signs and symptoms of psoriasis and provide an improved quality of life. In clinical studies, risankizumab demonstrated consistently high rates of skin clearance with a favorable benefit/risk profile. This is an important regulatory milestone in our relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions."

    The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision, valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. The Commission decision is anticipated within 67 days following the CHMP opinion.

    About the SKYRIZI (risankizumab) Phase 3 Psoriasis Program1-3

    The global Phase 3 psoriasis program evaluated more than 2,000 patients with moderate to severe plaque psoriasis throughout four pivotal studies. The studies include assessments of efficacy and safety of risankizumab at 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4 and every 12 weeks thereafter. Key measures of efficacy include measures of disease activity and skin clearance, including sPGA 0/1, PASI 90, and PASI 100 and health-related quality of life. More information on this program can be found at www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

    About risankizumab

    Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit.4 IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.6

    Risankizumab is under review with health authorities globally and is currently not approved by regulatory authorities. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    ###


    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.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.
    • 3.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.
    • 4.Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
    • 5.Leonardi, et al. Poster #9891. 2019 American Academy of Dermatology Annual Meeting. 2019.
    • 6.Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

    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.

    CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission1-3

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    NICE recommends VENCLYXTO®▼(venetoclax) in combination with rituximab on the NHS in England for people with previously treated Chronic Lymphocytic Leukaemia

    Press releases   •   Jan 18, 2019 10:33 GMT

    • Positive recommendation for VENCLYXTO (venetoclax) in final appraisal determination (FAD) means that, for the first time, people in England with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a chemotherapy-free option with a fixed treatment duration of 24 months.
    • NICE approval 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
    • Over 3,500 people in the UK are diagnosed with CLL every year, the most common type of blood cancer.2,3

    MAIDENHEAD, 18th January, 2019– AbbVie today announces that the National Institute for Health and Care Excellence (NICE) has published a positive final appraisal determination (FAD) recommending that VENCLYXTO® (venetoclax) in combination with rituximab (VenR) is made available for routine use by the National Health Service (NHS) in England for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. Please see the NICE website for the eligibility criteria here.

    David Innes, Chair of the CLL Support Association said: “The decision by NICE is extremely positive news for people living with relapsed or refractory CLL in England and has the potential to change the way we treat the disease. For many, a relapsed or refractory diagnosis can be daunting as when the disease comes back or progresses, prognosis can be poor. So to have NHS access to an effective chemotherapy-free option that is supported by robust clinical data and which patients do not have to take continuously is a welcome step forward. Patients will now have the chance to live longer with the added prospect of a treatment-free period.”

    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.3,4 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.5

    Professor Peter Hillmen, Consultant Haematologist, Leeds Teaching Hospitals NHS Trust and Coordinating Investigator of venetoclax studies in the UK, said: “NICE’s decision to recommend routine NHS access to venetoclax plus rituximab in the relapsed/refractory CLL setting now gives treating clinicians a new weapon in the fight against CLL. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. The demonstration of improved survival outcomes after cessation of therapy signals an important move to defined duration of targeted therapy. The cessation of therapy is a key advance in the treatment of CLL.”

    The NICE recommendation 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 with 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

    In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint. 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 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.6

    Recent post treatment follow-up data has provided evidence on long terms outcomes for VenR. 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.7

    Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to delivering breakthrough therapeutic options in CLL, an area where more treatments are urgently needed for patients. We have worked closely with NICE and the clinical and patient communities to ensure the timely appraisal of venetoclax plus rituximab in a concerted effort to bring much needed options to patients as quickly as possible. Alongside this, we have worked collaboratively with NHS England so that patients can access venetoclax plus rituximab without delay. We welcome this decision by NICE, and remain committed to improving patient outcomes in blood cancer.”

    The European Commission approved venetoclax plus rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who have received at least one prior therapy on 1st November 2018.8

    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 NICE guidance can be accessed here: https://www.nice.org.uk/guidance/gid-ta10160/documents/final-appraisal-determination-document

    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.com

    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

    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

    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: January 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: January 2019.

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

    5 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: January 2019.

    6 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.

    7 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.

    8 AbbVie News Centre. AbbVie receives European Commission Approval of Venetoclax Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy. Available at: https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-venetoclax-plus-rituximab-for-treatment-patients-with-chronic-lymphocytic-leukemia-who-have-received-at-least-one-prior-therapy.htm. Accessed January 2019.

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

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    HUMIRA® (adalimumab) 80 mg/0.8 mL Presentation intended as an Alternative Option for Therapy Induction and Maintenance Therapy is Now Available

    Press releases   •   Dec 03, 2018 09:25 GMT

    Maidenhead, UK, 1st December 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA® (adalimumab) 80 mg/0.8 mL. The presentation is designed as an alternative option for therapy induction for approved indications (Ps, CD, HS and Uveitis, and paed CD , HS and uveitis) and convenient dosing for patients that require a dose escalation (RA, Ps, CD, and HS, andpaed CD and adol HS).

    As with HUMIRA 40 mg/0.4 mL, which AbbVie introduced in 2016, the citrate buffer and other inactive ingredients have been removed and the formulation concentration increased allowing a reduction in injection volume by half. The formulation contains the same active ingredient, adalimumab and the efficacy and safety profile remains unchanged.1 A new presentation of HUMIRA 80 mg/0.8 mL is now available in England.

    "The launch of the HUMIRA 80 mg/0.8 mL formulation underscores our ongoing dedication to improving the patient experience through research and product enhancements,” said Alice Butler, Medical Director, AbbVie. “We remain committed to innovation in immunology and continue to strive to improve upon the therapeutic experience for patients and physicians.”

    Use of this presentation decreases the number of injections necessary by half, for the induction doses in the approved indications.1 In addition for patients that require a dose escalation to 40 mg weekly the availability of an 80 mg presentation allows patients to maintain their usual “every other week” dosing schedule.

    Both HUMIRA 40 mg/0.4 ml and HUMIRA 80 mg/0.8 mL contain the same active ingredient, adalimumab, meaning that the efficacy and safety profile remains unchanged.1

    -ENDS-

    Notes to editors

    About HUMIRA® (adalimumab)

    For further information, and recommended dosing of HUMIRA for each paediatric indication, please see the Summary of Product Characteristics: http://www.medicines.org.uk/emc.

    Important EU Safety Information

    HUMIRA 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. The use of HUMIRA 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 HUMIRA. 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. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

    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.

    • HUMIRA citrate-free 80 mg/0.8 mL formulation reduces the number of injections required to initiate HUMIRA therapy by half • Convenient 80 mg every other week dosing for patients that require dose escalation

    Read more »

    AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLYXTO®▼ (venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory CLL Who Completed the Fixed Treatment Course

    Press releases   •   Dec 01, 2018 22:45 GMT

    – The data demonstrated that VENCLYXTO® in combination with rituximab (VenR) reduced the risk of disease progression or death compared to a standard of care bendamustine plus rituximab (BR) after a median three-year follow-up1

    – Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax and remained off therapy for a median of 9.9 months, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively1

    – Three-year estimated overall survival (OS) was 87.9 percent in patients treated with VenRversus 79.5 percent in patients receiving BR1

    – Full results were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition

    MAIDENHEAD, 1ST December, 2018 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company today presented updated data from the pivotal Phase 3 MURANO trial of venetoclax (VENCLYXTO®) in combination with rituximab (VenR). The results at median follow-up of 36 months demonstrated continued substantial benefit with PFS and OS for patients with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL), treated with VenR having completed the fixed duration of therapy and stopped treatment, compared to patients treated with a standard of care regimen of bendamustine plus rituximab (BR).1 The estimated PFS rate in those 130 patients at 36 months was 71.4 percent (95% confidence interval [CI]: 0.64, 0.78) for patients treated with VenR compared with 15.2 percent (95% CI: 0.09, 0.21) for patients who completed treatment with a standard of care combination of BR (hazard ratio [HR]:0.16; 95% CI: 0.12, 0.23).1 The data were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition.

    Of the 130 patients who completed the two-year treatment course of venetoclax and remained off therapy for a median of 9.9 months (range: 1.4 to 22.5), six- and 12-month PFS estimates were 92 percent (95% CI: 0.87, 0.96) and 87 percent (95% CI: 0.81, 0.93), respectively. 1 At the time of analysis, the overall survival (OS) benefit estimated at three years was 8 percent higher in the VenR arm (87.9 percent) than in the BR arm (79.5 percent) (HR: 0.50; 95% CI: 0.30, 0.85).1

    “There is a need for a chemo-free option with a fixed treatment duration that can potentially provide prolonged progression-free survival, along with minimal residual disease negativity, in patients with relapsed or refractory chronic lymphocytic leukaemia,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of the Department of Hematology at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. “The results of this analysis showed that a high proportion of patients with relapsed or refractory chronic lymphocytic leukaemia who were treated with venetoclax in combination with rituximab maintained minimal residual disease negativity and progression-free survival well after completing the fixed treatment duration.”

    In the MURANO clinical trial, 78 percent of patients who completed the two-year treatment course of VenR without disease progression (N=114) also demonstrated minimal residual disease (MRD)-negativity in peripheral blood.1 MRD-negativity was a secondary endpoint assessed at the end of combination therapy (nine-month assessment1,2,3). MRD-negativity (also known as undetectable MRD) is an objective measure 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.4 Earlier prospective clinical trials in CLL patients have provided evidence that achieving MRD-negativity is associated with improved clinical outcomes.5

    “This analysis of the MURANO clinical trial showed that after patients had completed rituximab and a two-year course of venetoclax, and were off treatment for a median of 9.9 months, the disease did not progress in a substantial number of patients with relapsed or refractory chronic lymphocytic leukaemia, and in many of those patients the disease was undetectable in peripheral blood,” said Neil Gallagher, M.D., Ph.D., Head of Global Oncology Development, AbbVie. “These findings continue to support the use of venetoclax plus rituximab as a treatment with a fixed duration for patients with relapsed or refractory chronic lymphocytic leukaemia and are encouraging as we continue to advance the research and development of transformative medicines in blood cancers.”

    Safety data were consistent with the known safety profiles of each medicine alone. During the venetoclax single-agent treatment phase (N=171), 10 percent of patients had an adverse event (AE) leading to drug withdrawal, 4 percent had an AE leading to dose reduction, 26 percent had an AE leading to dose interruption, and 4 percent had a fatal AE (four other cancers, two cardiac, one pneumonia). Grade 3/4 AEs occurred in 35 percent of patients. The most common Grade 3/4 AEs were neutropenia (12 percent), anaemia (3 percent) and thrombocytopenia (2 percent). Seven percent of patients had a Grade 3/4 infection during the single-agent phase.1

    Venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by AbbVie and Roche. It is jointly commercialised 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.

    For the CHMP positive opinion for venetoclax in combination with rituximab, please visit: https://www.ema.europa.eu/documents/smop/chmp-summary-positive-opinion-venclyxto-ii/08_en.pdf

    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.com

    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. Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax in combination with rituximab is not currently approved for use in the UK.3

    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 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.

    2. VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.

    3. Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

    4. 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.

    5. 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.

    Read more »

    Efforts to Improve Patient Safety and Care Recognised in National Health Awards

    Press releases   •   Nov 20, 2018 15:27 GMT

    South Tees NHS Foundation Trust, Lymphoma Action and Arthur’s Choice win 2018 AbbVie Big Ideas for Better Health Awards

    AbbVie receives draft NICE guidance on VENCLYXTO®▼(venetoclax) plus rituximab for treating relapsed or refractory chronic lymphocytic leukaemia

    Press releases   •   Oct 26, 2018 14:59 BST

    MAIDENHEAD, Friday 26th October 2018 – AbbVie today received the draft guidance from the National Institute for Health and Care Excellence (NICE) not recommending venetoclax plus rituximab for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) in adults.

    Jérôme Bouyer, General Manager, AbbVie UK, said: “We are disappointed with the outcome of the draft decision, however this is not the final step in the appraisal and we are pleased NICE has recognised that venetoclax plus rituximab could be an important treatment option with an acceptable safety profile. We are also pleased to learn that patient experts would welcome a therapy with a fixed treatment duration in this setting. We remain committed to ensuring that patients with relapsed or refractory CLL have access to an important chemotherapy-free option.”

    “Our priority now will be to work collaboratively with NICE to ensure they have all the necessary data to inform a robust evaluation and our aim remains to facilitate NHS access to venetoclax plus rituximab as quickly as possible via routine commissioning or the Cancer Drugs Fund (CDF).”

    Over 3,500 people are diagnosed with CLL in the UK each year and the incidence has risen by 18% in less than 30 years.1 For those patients living with CLL requiringtreatment, the majority will eventually have their disease recur.2

    -Ends -

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

    For the CHMP positive opinion for venetoclax in combination with rituximab, please visit:

    https://www.ema.europa.eu/documents/smop/chmp-summary-positive-opinion-venclyxto-ii/08_en.pdf

    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.com

    Francesca Morley

    07795360167

    Francesca.Morely@virgohealth.com

    Notes to editors

    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 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: October 2018

    2 American Cancer Society. (2013) Leukemia – Chronic Lymphocytic. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed October 2018

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    AbbVie announces the introduction of an interim commercial offer to the NHS for HUMIRA® (adalimumab) from 1st November 2018

    Press releases   •   Oct 18, 2018 14:33 BST

    INTENDED FOR TRADE AND PHARMACEUTICAL PRESS ONLY

    Maidenhead, UK, 18th October 2018, AbbVie welcomes the intention expressed by NHS England on 15th October 2018, to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

    AbbVie supports the entry of new competitors and the approval of biosimilars that have demonstrated they are as safe and efficacious as their reference products. We remain committed to ensuring that our medicine remains a best value biologic option for the NHS, both now and in the future, and will introduce an interim commercial offer to the NHS to start from the 1st November. It is our position that patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.

    ENDS

    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 announces the introduction of an interim commercial offer to the NHS for HUMIRA® (adalimumab) from 1st November 2018

    Read more »

    AbbVie’s response* to NHS England’s announcement to switching to new versions of adalimumab

    Press releases   •   Oct 16, 2018 13:22 BST

    AbbVie today (16th October 2018) welcomes the intention expressed by NHS England to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

    Whilst we welcome the introduction of biosimilars that have demonstrated they are as safe and efficacious as their reference products, we remain committed to ensuring that our medicine remains a best value biologic option for the NHS, both now and in the future, and it is our position that patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.

    Furthermore building on the strength of our continuous 20 years of investment and a strong foundation in immunology, we are advancing an extensive portfolio, with several molecular compounds being evaluated across multiple immune-mediated conditions. These investigational medicines are designed to target different immune system pathways. We believe that these compounds will provide us with a competitive portfolio in immunology that will help us maintain our therapeutic leadership, drive continued growth and make an ongoing impact on patients’ lives.

    *This statement is provided in direct response to the NHS England press release ‘NHS set to save £150 million by switching to new versions of most costly drug’, issued 15th October 2018, during which time the tender process is still on-going. 

    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 today (16th October 2018) welcomes the intention expressed by NHS England to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

    Read more »

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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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