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

Press release   •   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.