Eli Lilly’s Omvoh recommended by CHMP for approval in EU

Eli Lilly (LLY) and Company announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for Omvoh, an interleukin-23p19 antagonist, for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. Omvoh was previously approved in the European Union, U.S. and Japan in 2023 as a first-in-class treatment for adults with moderately to severely active ulcerative colitis and is approved in 44 countries around the world. This positive opinion marks the next step toward European regulatory approval of Omvoh for patients with moderately to severely active Crohn’s disease, and it is now referred to the European Commission for final action. The European Commission’s decision is expected in the next one to two months.