FDA Approves Risankizumab for Crohn Disease

The US Food and Drug Administration (FDA) has approved the IL-23 inhibitor risankizumab for the treatment of adults with moderate-to-severe Crohn disease.

This approval is based on results of 2 induction and 1 maintenance clinical trials. In the phase 3, ADVANCE and MOTIVATE induction trials, there was a significant greater proportion of patients treated with risankizumab who achieved both endoscopic and clinical remission when compared to the placebo. There were also clinical response and remission achieved as early as week 4, with a significantly greater proportion of patients achieving those in the risankizumab groups.

In the phase 3, FORTIFY maintenance trial, there was a significantly greater proportion of patients treated with risankizumab who achieved the primary endpoints of endoscopic and clinical remission at 52 weeks, compared to the placebo. There is currently on open-label extension of FORTIFY to evaluate the long-term safety of risankizumab.

Risankizumab has previously been approved in the US to treat certain patients with psoriasis, and psoriatic arthritis. Currently, there are ongoing phase 3 trials of risankizumab for the treatment of psoriasis, Crohn disease, ulcerative colitis, and psoriatic arthritis.

Reference:
SKYRIZI (risankizumab-rzaa) receives FDA approval as the first and only specific interleukin-23 (IL-23) to treat moderate to severely active Crohn’s disease in adults. News Release. AbbVie; June 17, 2022.