Lilly's (LLY.US) mirikizumab, an IL-23p19 antibody, has been approved for a new Crohn's disease indication.

On January 15, Eli Lilly (LLY.US) announced that its IL-23p19 monoclonal antibody mirikizumab (Omvoh) has been approved for its second indication, for the treatment of adults with moderate to severe active Crohn's disease. Mirikizumab, which was approved in October 2023 as a first-in-class therapy for the treatment of moderate to severe active ulcerative colitis (UC) in adults, is now approved for the treatment of two types of inflammatory bowel disease (IBD). Mirikizumab reduces inflammation in the gastrointestinal tract by targeting the specific protein IL-23p19. Mirikizumab is the first biologic therapy to be approved for a Crohn's disease indication with two-year Phase III efficacy data. The approval was based on the positive results of the Phase III VIVID-1 study in adult patients with moderate to severe active Crohn's disease who had an inadequate response, lost response, or were intolerant to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF blockers, integrin receptor antagonists).