CHMP Recommends EU Approval for Lilly's Omvoh® for Moderate to Severe Crohn's Disease

20 December 2024
Eli Lilly and Company has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for Omvoh® (mirikizumab) to treat adults with moderately to severely active Crohn's disease who have not responded to or cannot tolerate existing treatments, including both conventional and biologic therapies. Omvoh is an interleukin-23p19 (IL-23p19) antagonist, and its approval would provide a new option for patients who struggle to achieve or sustain remission with current therapies.

The potential of Omvoh as a novel treatment is significant, according to Stefan Schreiber, M.D., Ph.D., a director at the University Hospital Schleswig-Holstein in Germany. Schreiber highlights that many patients with Crohn’s disease do not achieve long-term remission with current treatments. Omvoh offers the possibility of substantial control over the disease, alleviating severe symptoms like bowel urgency and promoting intestinal healing, as confirmed by endoscopic and histologic evaluations.

Omvoh had already been approved in 2023 for treating ulcerative colitis in the European Union, the United States, and Japan. It is available in 44 countries worldwide. The recent positive opinion represents a step toward expanding its use for Crohn’s disease in Europe, with a final decision expected from the European Commission within one to two months.

The CHMP's endorsement is based on comprehensive data from the Phase 3 VIVID-1 study, which assessed the safety and efficacy of mirikizumab against placebo and a control treatment, ustekinumab, in adults with active Crohn's disease. The study demonstrated significant improvements in patients receiving mirikizumab compared to those on placebo, achieving better outcomes in endoscopic response, clinical remission, and secondary endpoints like steroid-free clinical remission and endoscopic results measured at 12 and 52 weeks. The trial also reported enhancements in bowel urgency severity using a patient-centric scale developed by Lilly.

Notably, VIVID-1 is the first pivotal trial in Crohn's disease to show improvements in histologic outcomes based on strict criteria aligned with the European Crohn's and Colitis Organisation's standards for mucosal histopathology. Better histologic healing is linked to improved long-term outcomes for Crohn's disease patients. The safety profile of mirikizumab in treating Crohn’s disease is consistent with its known effects in patients with ulcerative colitis, and findings from VIVID-1 were published in The Lancet.

Furthermore, ongoing studies have presented long-term efficacy and safety data for both ulcerative colitis and Crohn's disease, shared at recent medical conferences. Mark Genovese, M.D., a senior vice president at Lilly, emphasized the impact of Crohn's disease symptoms like bowel urgency on patients' quality of life and expressed optimism that Omvoh could significantly enhance treatment options for those affected by inflammatory bowel disease.

Lilly has submitted regulatory applications for Omvoh in treating Crohn's disease in various countries, including the United States and Japan, with decisions anticipated starting in the first half of 2025.

Crohn's disease is a chronic inflammatory bowel condition that can lead to serious complications and significantly impacts patients' lives. Many patients do not achieve satisfactory results with current therapies, and those with prior biologic treatment failures may find it particularly challenging to manage their condition.

The VIVID-1 trial was a Phase 3, randomized, double-blind study evaluating mirikizumab's efficacy compared to placebo and ustekinumab in adults with active Crohn's disease. In the study, participants received mirikizumab intravenously and then subcutaneously, with nearly half having experienced previous biologic treatment failure.

Omvoh is initially indicated for ulcerative colitis treatment, and its potential expansion to Crohn's disease could provide a significant new therapeutic option for individuals struggling with the disease worldwide.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!