AbbVie has announced its submission of a biologics license application (BLA) to the FDA for the review of risankizumab, an investigational therapy for the treatment of patients with moderate to severe plaque psoriasis.

The BLA for the interleukin-23 (IL-23) inhibitor will be supported by data from a global phase 3 psoriasis trial program consisting of more than 2000 patients from 4 clinical trials— ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent.

"The risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases," Michael Severino, MD, the executive vice president of research and development, and chief scientific officer at AbbVie, said in a statement. "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 therapy met all co-primary and ranked secondary endpoints in the 4 trials without displaying any new safety signals, according to AbbVie.

 In ultIMMA-1 and ultIMMa-2, the therapy was compared with ustekinumab and placebo, and the results showed that after 16 weeks, 75% of patients on the Il-23 ihibitor in both studies achieved PASI 90 compared to 5 percent of patients receiving placebo in ultIMMa-1, and 2 percent receiving placebo in ultIMMa-2. These response rates were also significantly greater than ustekinumab in 90% improvement of Psoriasis Area and Severity Index (PASI 90) response rates—42% in ultIMMa-1, and 48% in ultIMMa-2.

Additionally, a static Physician Global Assessment score of clear or almost clear (sPGA 0/1) was reached by 88% and 84% of patients on risankizumab in ultIMMa-1 and ultIMMa-2, respectively, in comparison with 8% and 5% of patients on placebo. Those rates were also significantly greater than the ustekinumab’s, which were 63% for sPGA 0/1 in ultIMMa-1, and 62% in ultIMMa-2.

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