Eli Lilly and Company (NYSE: LLY) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh^® (mirikizumab), an interleukin-23p19 (IL-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.

"I am excited for the potential of Omvoh as a novel treatment option for patients suffering from moderately to severely active Crohn's disease, since the majority of patients do not achieve remission on current therapies or cannot maintain it long term," said Stefan Schreiber, M.D., Ph.D., director of the Clinic for Internal Medicine I at Kiel Campus of the University Hospital Schleswig-Holstein, Kiel, Germany. "With Omvoh, many patients can achieve comprehensive control of their disease, including relief from disruptive symptoms such as bowel urgency and control of intestinal inflammation defined by visible endoscopic and histologic healing."

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 (UC) 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.

The positive CHMP opinion is supported by data from the Phase 3 VIVID-1 study evaluating the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. In VIVID-1, patients treated with mirikizumab achieved statistically significant improvement compared to placebo-treated patients on both co-primary endpoints, composite endoscopic response and composite clinical remission, and all major secondary endpoints, including composite steroid-free clinical remission and endoscopic outcomes, at Week 12 and Week 52. Additionally, improvements in bowel urgency severity were achieved, as measured by a patient-centric, 11-point scale developed by Lilly. VIVID-1 is the first pivotal Crohn's disease trial to report improvements in histologic outcomes with strict definitions that were aligned with the European Crohn's and Colitis (ECCO) position statement on mucosal histopathology. Histologic healing, as evaluated by these histologic measures of inflammation, is associated with better long-term outcomes for patients with Crohn's disease. Mirikizumab's overall safety profile in patients with moderately to severely active Crohn's disease was consistent with its known safety profile in patients with UC. Results from the VIVID-1 study were recently published in The Lancet.

In addition, long-term, multi-year, sustained efficacy and safety data for both UC and Crohn's disease were also recently presented at the American College of Gastroenterology (ACG) Annual Meeting in October.

"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," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Given the efficacy we saw on clinical remission and endoscopic response, combined with the 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."

Lilly has submitted marketing applications for Omvoh in Crohn's disease around the globe, including the U.S. and Japan. Decisions are expected from these regulatory authorities starting in the first half of 2025.