Eli Lilly's IL-23p19 monoclonal antibody mirikizumab approved for new indication in Crohn's disease.

On January 15th, Eli Lilly (LLY.US) announced that its IL-23p19 monoclonal antibody mirikizumab (Omvoh) has been approved by the FDA for a second indication, for the treatment of moderate to severe active Crohn's disease in adults. Mirikizumab, after being approved in October 2023 as a first-in-class therapy for moderate to severe active ulcerative colitis (UC) in adults, is now approved for the treatment of two types of inflammatory bowel disease (IBD). Mirikizumab works by targeting the specific protein IL-23p19 to reduce inflammation in the gastrointestinal tract. Mirikizumab is the first biologic therapy in over 15 years to have Phase III efficacy data disclosed at the time of approval for the Crohn's disease indication. This approval is based on positive results from the Phase III VIVID-1 study of mirikizumab in adults with moderate to severe active Crohn's disease who had inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF blockers, integrin receptor antagonists).