FDA approves AbbVie's risankizumab-rzaa (Skyrizi) for moderate to severe ulcerative colitis.

The FDA has approved AbbVie's risankizumab-rzaa (Skyrizi) for treating adults with moderately to severely active ulcerative colitis (UC). This marks the first approval of an IL-23 specific inhibitor for both moderate to severe UC and moderate to severe Crohn disease. The decision is based on data from two phase 3 clinical trials which demonstrated clinical remission and endoscopic improvement.

June 18, 2024
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