AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI™) for the Treatment of Moderate to Severe Plaque Psoriasis

- 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 Commission(1-3)

- 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(1-3)

- 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 subunit(4)

News provided by

AbbVie

Mar 01, 2019, 07:00 ET

NORTH CHICAGO, Ill., March 1, 2019 /PRNewswire/ -- 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 patients who 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. At one year, more than 50 percent of patients receiving risankizumab achieved completely clear skin. 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 Program^1-3

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 SKYRIZI (risankizumab)

SKYRIZI 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 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease and psoriatic arthritis are ongoing, and it is also being investigated to treat ulcerative colitis.^7-11

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

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.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

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:

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.
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.
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.
Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
Leonardi, et al. Poster #9891. 2019 American Academy of Dermatology Annual Meeting. 2019.
Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (lIMMitless). Clinicaltrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on February 8, 2019.
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104413. Accessed on February 8, 2019.
A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (IMMpact2). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03671148. Accessed on February 8, 2019.
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2019. https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on February 8, 2019.
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2019. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on February 8, 2019.