US pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults.

Omvoh is now approved in the United States for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation. Lilly says that Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn's disease at the time of approval.

The FDA decision was based on positive results from the Phase 3 VIVID-1 study of Omvoh in adults with moderately to severely active Crohn's disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) and/or biologics (TNF blockers, integrin receptor antagonists).