Lilly gets positive EU regulatory opinion for Omvoh for Crohn’s

Eli Lilly (NYSE:LLY) has received a positive recommendation for approval from European regulators for its drug Omvoh in the treatment of Crohn’s disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for Omvoh 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, according to a statement.

The European Commission is expected to decide within the next two months on whether to approve the product.

Lilly (NYSE:LLY) has also applied to have Omvoh approved by the FDA for the treatment of moderately to severely active Crohn’s disease. A decision expected in the first half of 2025.

Omvoh is already approved in the EU, U.S. and Japan for the treatment of moderately to severely active ulcerative colitis.