AbbVie Submits Application to EMA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

AbbVie 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.  Across all four studies, risankizumab met all co-primary and ranked secondary endpoints with no new safety signals across the Phase 3 program. 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.