– In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1)
– The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3)
– 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)
AbbVie, a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the FDA for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis.
“The risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Risankizumab has the potential to be an important treatment option for people living with plaque psoriasis and we look forward to working with the FDA throughout the review process.”
The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe chronic plaque psoriasis across four 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.1-3 Top-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.
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)
Filed Under: Drug Discovery
