AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.
Risankizumab is a humanized monoclonal antibody, designed to selectively inhibit IL-23 by binding to its p19 subunit.
IL-23 is an important cytokine involved in inflammatory processes, and is believed to be associated with various chronic immune-mediated diseases.
AbbVie has filed its BLA based on the data collected from the global risankizumab phase 3 psoriasis program.
Comprising four phase 3 trials – ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, the risankizumab phase 3 psoriasis program evaluated the drug in more than 2,000 patients with moderate to severe chronic plaque psoriasis.
In all the four late-stage trials, risankizumab met all co-primary and ranked secondary endpoints while showing no new safety signals.
AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: “The risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases.
“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.”
Currently, risankizumab, which is part of a collaboration with Boehringer Ingelheim, is being evaluated in phase 3 trials in psoriasis and Crohn’s disease. AbbVie is investigating its ability to treat psoriatic arthritis as well.
The company is also planning to hold trials in the future to evaluate risankizumab in ulcerative colitis. Risankizumab is yet to be approved by regulatory authorities for any indication.
In a separate development, AbbVie said that its AK1-selective inhibitor upadacitinib met the primary endpoint of ACR20 in the phase 2b/3 SELECT-SUNRISE clinical trial in adult patients with moderate to severe rheumatoid arthritis.
Upadacitinib is being evaluated in the trial held in Japan against placebo in patients who are on a stable dose of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and who did not show an adequate response to csDMARDs.