18 June 2024 - Approval supported by two Phase 3 clinical trials that evaluated Skyrizi for the treatment of moderate to severe ulcerative colitis: a 12 week induction study, INSPIRE,1 and a 52 week maintenance study, COMMAND.
AbbVie today announced the US FDA has approved Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.