AbbVie Submits BLA for Risankizumab for Moderate to Severe Plaque Psoriasis

AbbVie has announced its submission of a biologics license application (BLA) to the US Food and Drug Administration (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.

When compared with adalimumab in the IMMvent trial, 72% of patients on risankizumab achieved PASI 90 versus 47% of patients on adalimumab. A sPGA 0/1 score was achieved by 84% of the risankizumab arm, compared to 60% of the adalimumab arm after 16 weeks. Furthermore, PASI 100 (complete skin clearance) was reached by 40% of the risankizumab arm compared to 23% of the adalimumab arm by that same time period.

In December, AbbVie announced that the therapy had met all primary endpoints of the IMMhance study and that 47% of patients receiving the IL-23 inhibitor achieved PASI 100, compared to 1% on placebo, at week 16. Additionally, 87% of patients that achieved sPGA 0/1 maintained this response after 52 weeks.

The therapy is part of a collaboration between AbbVie and Boehringer Ingelheim.