Eli Lillys Omvoh Approved by FDA for Treatment of Moderately to Severely Active Crohns Disease


Published: 27 Jan 2025

Author: Precedence Research

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Eli Lilly and Company reached an important milestone with the U.S. Food and Drug Administration's approval of Omvoh® (mirikizumab-mrkz) for treating adults with moderately to severely active Crohn's disease. This was the second approval the company received from the FDA, following clearance in October 2023 to treat UC. This represented a landmark treatment for two significant types of inflammatory bowel disease, namely IBD. Omvoh specifically targets interleukin-23p19 (IL-23p19), a protein that plays a vital role in initiating inflammation within the intestine and is the first biologic approved in more than 15 years to demonstrate that a two-year Phase 3 efficacy assessment was conducted in Crohn's disease.

Elil Lilly

The approval is based on the VIVID-1 study, which has shown that the drug achieves clinical remission and visible intestinal healing in amounts that are significant for a substantial number of patients who do not respond well to currently available therapies. Omvoh's introduction addresses the desperate needs of patients with severe Crohn's disease regarding their day-to-day living. There is a possibility of long-term control and eventual quality-of-life improvements. Moreover, Eli Lilly should continue to enhance coverage worldwide, demonstrating a commitment to raising standard care levels among seriously ill individuals suffering from chronic diseases.

Addressing a Substantial Patient Burden

The Crohn's & Colitis Foundation has accepted Omvoh, a drug for the treatment of Crohn's disease, based on data from the Phase 3 VIVID-1 trial. The study was conducted in adults with moderately to severely active Crohn's disease who had an inadequate response or intolerance to corticosteroids, immunomodulators, and/or biologics. The major findings were: 53% of the patients receiving Omvoh treatment achieved clinical remission at one year; 46% of the patients treated with Omvoh showed visible intestinal healing; and 32% of the patients experienced early improvement in endoscopic response at three months. 

The patients were administered an initial dose of 900 mg intravenously and then a maintenance dose of 300 mg subcutaneously every four weeks for 40 weeks. Omvoh is also being assessed in the open-label extension (OLE) VIVID-2 study. The safety profile of Omvoh in Crohn's disease is consistent with that observed in ulcerative colitis. The most common adverse reactions reported in at least 5% of patients include upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver enzymes.

Insights from Clinical Experts

According to Dr. Marla Dubinsky, chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children's Hospital, the FDA approval of Omvoh may bring patients with Crohn's disease long-term remission and visible healing of the intestinal lining, despite the failure of other treatments. Lilly is working with insurers and health systems to ensure that Omvoh will be covered at the first-line biologic level, including securing coverage from two of the three largest pharmacy benefit managers. Co-pay assistance is available through Lilly Support Services™ for eligible, commercially insured patients.

Global Market Prospects

Eli Lilly filed marketing applications in the European Union and Japan, with additional submissions set to be completed worldwide for Omvoh in Crohn's disease and ulcerative colitis. In addition, Omvoh has already been approved in 44 countries for treating ulcerative colitis. According to Dr. Daniel M. Skovronsky, Chief Scientific Officer at Lilly, "Omvoh offers a treatment option that provides control of the underlying disease for many years, fulfilling critical patient needs." This is a major advancement in the management of IBD, bringing hope and a better quality of life to patients around the world.

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