08:47 AM EST, 12/13/2024 (MT Newswires) -- Eli Lilly ( LLY ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use had recommended its experimental therapy, Omvoh, for treating adults with moderately to severely active Crohn's disease.
The company said Omvoh, also known as mirikizumab, was approved in 2023 in the EU, US and Japan to treat adults with moderately to severely active ulcerative colitis.
The European Commission's decision on its use for Crohn's disease is expected in the next one to two months, the company added.
The drugmaker said the recommendation was based on data from the phase 3 study, which demonstrated that patients treated with mirikizumab, showed statistically significant improvements over placebo in composite endoscopic response and clinical remission.
Lilly said it has submitted marketing applications for Omvoh in Crohn's disease globally, with decisions expected from regulatory authorities in the US and Japan in H1 2025.