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Tuesday, June 18, 2024

FDA Approves AbbVie SKYRIZI for Ulcerative Colitis

 

  • 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, COMMAND2
  • Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint1,2
  • SKYRIZI is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease

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