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

– 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

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

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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