FDA approves Abbvie's Skyrizi for ulcerative colitis

FDA approves Abbvie's Skyrizi for ulcerative colitis

Source: 
PR Newswire
snippet: 
  • 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