Key Insights:
- The FDA has approved Skyrizi (risankizumab-rzaa; AbbVie) for treating moderately to severely active ulcerative colitis in adults, marking it as the first specific anti–interleukin 23 monoclonal antibody for this condition.
- The approval is based on data from two phase 3 clinical trials (INSPIRE and COMMAND) showing significant clinical remission and endoscopic improvement in patients.