AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
April 27, 2018
AbbVie(NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration(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.
About the Risankizumab Phase 3 Psoriasis Program1-3 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 diseasea 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.4IL-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.