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

– 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 psoriasis^1-4

– 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 time^5-6,7

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)