Edward V Loftus, Jr, MD: Discussing FDA Approval of Risankizumab (Skyrizi) in Ulcerative Colitis

The recent US Food and Drug Administration (FDA) approval of risankizumab-rzaa (Skyrizi) for adults with moderately to severely active ulcerative colitis (UC) made it the first interleukin (IL)-23 specific inhibitor approved for both UC and Crohn disease (CD).
The decision, announced on June 18, 2024, was based on data from a pair of phase 3 clinical trials: a 12-week induction study, INSPIRE, and a 52-week maintenance study, COMMAND. Findings showed clinical remission, the primary endpoint in both studies, was achieved, along with endoscopic improvement, a key secondary endpoint.
An IL-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit, risankizumab’s approval in UC adds to its growing number of approved indications across immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and CD.
“In a complex world, even providers like to have simple algorithms, so this might be simple to say ‘Okay, I know this one is approved for both [ulcerative colitis and Crohn’s disease]’ and so you might be more likely to use it,” Loftus concluded.
Check out the rest of HCPLive's coverage of the FDA decision:
www.hcplive.com/view/fda-appr...
www.hcplive.com/view/edward-v...
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