The FDA has approved mirikizumab (Omvoh, Lilly) as a first-line therapy for moderate to severe Crohn’s disease in adults.
The interleukin-23p19 agonist initially was approved in 2023, for treatment of moderate to severe ulcerative colitis. The drug’s approval for moderate to severe CD follows positive results of the phase 3 VIVID-1 study, which included adults who had an inadequate response, loss of response or intolerance to corticosteroids, immunomodulators and/or biologics,