RSS FDA Approves Lilly's Omvoh For Crohn's Disease Treatment

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 RSS FDA Approves Lilly's Omvoh For Crohn's Disease Treatment

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Eli Lilly and Co. (LLY) has received approval from the U.S. Food and Drug Administration for Omvoh (mirikizumab-mrkz), designed to treat adults with moderately to severely active Crohn's disease.

With this U.S. approval, Omvoh is now authorized for use in two forms of inflammatory bowel disease (IBD). It follows its October 2023 approval as the first treatment of its kind for adults dealing with moderately to severely active ulcerative colitis (UC).

According to Eli Lilly, Omvoh functions by reducing gastrointestinal tract inflammation through the targeting of interleukin-23p19 (IL-23p19), a protein that plays a crucial role in intestinal inflammation. Remarkably, Omvoh is the first biologic therapy in over 15 years to reveal two-year Phase 3 efficacy data for Crohn's disease at the time of its approval.

Eli Lilly has also filed for Omvoh's marketing authorization for Crohn's disease in various regions worldwide, including the European Union and Japan, with further regulatory applications anticipated. As for ulcerative colitis, Omvoh has already been approved in 44 countries globally.

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