Lilly has filed marketing applications for the therapy in Crohn’s disease treatment across various worldwide markets. Credit: JHVEPhoto/Shutterstock.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Omvoh (mirikizumab) for approval in the European Union (EU) to treat adults with moderately to severely active Crohn’s disease.

An interleukin-23p19 (IL-23p19) antagonist, Omvoh was approved in 2023 in the US, Japan and the EU for ulcerative colitis (UC) treatment. It is also approved in 44 countries globally.

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The positive CHMP opinion could lead to expanded use in the EU, pending the European Commission’s final decision anticipated by early spring 2025.

The recommendation is based on the outcomes from the treat-through, randomised, double-blind Phase III VIVID-1 trial, which assessed the efficacy and safety of the therapy against placebo and ustekinumab in adults with the condition.

It marks a step towards full regulatory endorsement in the European region.

This is the first pivotal trial for the disease to report improvements in histologic outcomes, aligning with the European Crohn’s and Colitis Organisation’s (ECCO) statement on mucosal histopathology.

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The company has filed marketing applications for the therapy in Crohn’s disease treatment across worldwide markets, including the US and Japan, with regulatory decisions anticipated in the first half of 2025.

Lilly immunology development senior vice-president Mark Genovese stated: “Disruptive symptoms of Crohn’s disease, such as bowel urgency, can interfere with all aspects of life, leaving many people searching for treatments that can help them fully participate in the things that they enjoy.

“Given the efficacy we saw on clinical remission and endoscopic response, combined with improvements in bowel urgency and histological inflammation, this positive CHMP opinion for Omvoh brings us a step closer to advancing care for more people with inflammatory bowel disease around the world.”

In early December 2024, Lilly announced a $3bn investment to expand its manufacturing facility in Kenosha County in the US state of Wisconsin.