AbbVie Submits Marketing Authorization Application to the European Medicines Agency for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

- Application supported by four pivotal Phase 3 trials evaluating more than 2,000 patients with moderate to severe plaque psoriasis (1-3)

- In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1)

- Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)

News provided by

AbbVie

May 01, 2018, 08:45 ET

NORTH CHICAGO, Ill., May 1, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for the treatment of patients with moderate to severe plaque psoriasis.

"The risankizumab submission to the EMA marks another significant milestone in helping to advance treatment for people living with immune-mediated diseases," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Many psoriasis patients are still battling this disease and the impact it has on their lives. Risankizumab has the potential to be an important new treatment option and we look forward to working with the EMA throughout the review process."

The marketing authorization application is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies: ultIMMA-1, ultIMMa-2, IMMhance and IMMvent.^1-3 Across all four studies, risankizumab met all co-primary and ranked secondary endpoints with no new safety signals across the Phase 3 program.^1-3Top-line results of these clinical studies were previously announced in October and December 2017. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally.

About the Risankizumab Phase 3 Psoriasis Program^1-3

The global risankizumab Phase 3 psoriasis program evaluates more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal studies. The studies include assessments of efficacy, safety and tolerability of risankizumab. Key measures of efficacy include measures of disease activity and skin clearance, including PASI 90, PASI 100 and sPGA 0/1, as well as long-term clinical outcomes. 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.⁵ Phase 3 trials of risankizumab in psoriasis and Crohn's disease are ongoing, and it is also being investigated to treat psoriatic arthritis.^6,7 Future trials are planned to investigate risankizumab in ulcerative colitis.^8,9

Risankizumab is not approved by regulatory authorities. Safety and efficacy have not been established.

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 or LinkedIn.

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.

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¹ Gordon K, et al. Efficacy and Safety of Risankizumab: Results from Two Double-Blind, Placebo- and Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque Psoriasis. American Academy of Dermatology. February 2018.

² AbbVie. Data on File, ABVRRTI65374.

³ AbbVie. Data on File, ABVRRTI65055.

⁴ Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.

⁵ Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

⁶ A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on February 2, 2018.

⁷ BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on February 2, 2018.

⁸ 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.
2018. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on February 2, 2018.

⁹ A 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. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on February 2, 2018.

SOURCE AbbVie