Eli Lilly: positive EU opinion for Crohn's disease

(CercleFinance.com) - Eli Lilly has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Omvoh (mirikizumab), for adults with moderately to severely active Crohn's disease.


The CHMP's positive opinion is supported by data from the phase 3 VIVID-1 study evaluating the safety and efficacy of mirikizumab versus placebo and active control (ustekinumab) in adults with moderately to severely active Crohn's disease.

In the VIVID-1 study, mirikizumab-treated patients achieved a statistically significant improvement over placebo-treated patients for both co-primary endpoints.

' With Omvoh, many patients can achieve complete control of their disease, including relief of disruptive symptoms such as bowel urgency and control of bowel inflammation defined by visible endoscopic and histological scarring. ' said Stefan Schreiber, M.D., Ph.D., Director of the Internal Medicine I Clinic at the Kiel Campus of the University Hospital of Schleswig-Holstein. Kiel, Germany.

Lilly has also submitted Omvoh for approval in the U.S. for the treatment of moderately to severely active Crohn's disease, with a decision expected in the first half of 2025.

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