Eli Lilly has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Omvoh (mirikizumab) as a treatment for adults with moderate to severe Crohn’s disease.
This marks the second major approval for Omvoh in the realm of inflammatory bowel diseases, following its earlier authorization in October 2023 for ulcerative colitis.
Omvoh is a groundbreaking biologic therapy that targets interleukin-23p19 (IL-23p19), a protein responsible for driving inflammation in the gastrointestinal tract.
By specifically inhibiting this protein, Omvoh effectively reduces inflammation and helps manage symptoms in patients with inflammatory bowel disease. Notably, it is the first biologic treatment in over 15 years to disclose two-year Phase 3 efficacy data for Crohn’s disease at the time of its approval.
Pivotal Trial Results
The FDA’s decision was informed by results from the Phase 3 VIVID-1 study, which evaluated Omvoh’s effectiveness in adults who had an inadequate response or intolerance to conventional treatments such as corticosteroids, immunomodulators, and biologics. The trial met its primary endpoints, demonstrating impressive results:
Clinical remission at one year: 53% of patients treated with Omvoh achieved clinical remission compared to 36% of those on placebo.
Endoscopic response at one year: Visible healing of the intestinal lining was observed in 46% of Omvoh-treated patients versus 23% on placebo.
Early improvement in three months: 32% of Omvoh patients experienced early healing compared to 11% in the placebo group.
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Long-Term Effectiveness
The ongoing VIVID-2 study, an open-label extension, continues to evaluate Omvoh’s long-term safety and efficacy. Results from VIVID-2 show that among patients who achieved endoscopic response at one year during VIVID-1, more than 80% maintained this response after two years of continuous treatment. Similarly, nearly 90% of patients who reached clinical remission and endoscopic response at one year maintained clinical remission through two years of treatment.
The approval of Omvoh for Crohn’s disease offers a new treatment option for individuals living with this challenging condition. Its ability to provide both short-term symptom relief and sustained long-term benefits establishes it as a vital advancement in the treatment of inflammatory bowel diseases.
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