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Eli Lilly’s Omvoh®: A Breakthrough in Crohn's Disease Treatment

Eli Lilly and Company has recently announced promising results from its VIVID-2 open-label extension study concerning the drug Omvoh® (mirikizumab-mrkz) for Crohn's disease. Over two years, a significant percentage of patients achieved and maintained clinical remission and endoscopic response, showcasing Omvoh's potential as a long-term treatment option for individuals suffering from this challenging condition.

The VIVID-2 study demonstrated that more than 90% of patients who entered clinical remission after one year of Omvoh treatment sustained that state at the two-year mark. Additionally, nearly 90% of patients who had an endoscopic response after one year continued to show healing of their intestinal lining after the same duration. These findings mark Omvoh as the first IL-23p19 antagonist to exhibit sustained efficacy and safety in both Crohn's disease and ulcerative colitis over a multi-year period.

Understanding the Mechanism

Omvoh functions by targeting interleukin-23p19 (IL-23p19), which plays a crucial role in the inflammation associated with diseases like Crohn's. Dr. Edward Barnes, an Associate Professor of Medicine at the University of North Carolina at Chapel Hill, emphasized the significance of these findings. He noted that many patients with Crohn's disease have experienced limitations with existing therapies, either facing ineffectiveness or reduced efficacy over time. The positive long-term data offers renewed hope for both patients and healthcare providers regarding treatment options.

Participants of the VIVID-2 study were those who had previously been part of the Phase 3 VIVID-1 trial and showed an endoscopic response after the first year of treatment. Upon analyzing the data after two years, the results were enlightening:

• - 92.9% of patients who were in clinical remission at one year maintained that remission at two years, measured by the Crohn's Disease Activity Index (CDAI).
• - 87.6% of patients continued to display endoscopic response, indicated by a significant reduction in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
• - For patients in endoscopic remission, 78.6% remained in remission after two years.

Encouragingly, 60.8% of patients who were not in clinical remission at one year achieved remission during the second year, and 35.4% of those not initially in endoscopic remission achieved this status in the following year. This data reinforces the drug's potential versatility and effectiveness in treating a diverse patient population.

Safety Profile Assessment

When evaluating the long-term safety profile of Omvoh in the VIVID-2 study, results remained consistent with earlier known safety data. Over the second year, 6.8% of patients reported serious adverse events, and only 0.8% discontinued treatment due to adverse reactions. This suggests a tolerable safety profile for patients undergoing treatment with Omvoh.

Mark Genovese, M.D., senior vice president of Lilly's Immunology development, articulated the company’s commitment to improving treatment options for patients with inflammatory bowel disease. He stated, “Lilly is setting a high bar for sustained and durable treatment response.” These results play a vital role in solidifying Omvoh's status as an effective option for managing Crohn's disease, along with its well-established profile for ulcerative colitis.

The U.S. FDA granted approval for Omvoh for moderate to severe Crohn's disease in January 2025, following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December 2024. Omvoh is also making strides toward approval in various markets, including Canada, Japan, and China, while already being approved in 44 countries for ulcerative colitis.

Future of Omvoh and Ongoing Research

Lilly continues to explore the efficacy of Omvoh, conducting ongoing trials focused not only on adult patients but also on pediatric populations. The long-term safety and efficacy of Omvoh will remain a priority in clinical studies, with the anticipation of further data supporting its efficacy in real-world applications.

In summary, the VIVID-2 study results represent a significant milestone in Crohn's disease treatment, offering a beacon of hope for patients seeking effective long-term management of their condition. With demonstrated efficacy and an encouraging safety profile, Omvoh has the potential to change the landscape of treatment for inflammatory bowel diseases significantly.

For further updates, keep an eye on developments from Eli Lilly as they continue to innovate and expand treatment options for patients worldwide.