A New Hope for Crohn’s Patients: Eli Lilly’s Omvoh Gains FDA Approval”

On January 15, 2025, the U.S. Food and Drug Administration (FDA) granted approval to Eli Lilly’s Omvoh® (mirikizumab-mrkz) for the management of moderately to severely active Crohn’s disease in adult patients. This approval marks a significant expansion of Omvoh’s therapeutic indications, as it had previously received FDA approval in October 2023 for the treatment of moderately to severely active ulcerative colitis, another type of inflammatory bowel disease (IBD).

The FDA’s decision to approve Omvoh for Crohn’s disease was supported by robust clinical evidence derived from the Phase 3 VIVID-1 study. This pivotal trial was designed as a randomized, placebo-controlled investigation involving a cohort of adults with moderately to severely active Crohn’s disease. Importantly, participants in the trial had demonstrated inadequate responses or exhibited intolerance to conventional therapies, which included corticosteroids, immunomodulators, and other biologic treatments. The results of the VIVID-1 study revealed that 53% of the patients administered Omvoh achieved clinical remission after one year of treatment, a notable improvement compared to 36% of patients in the placebo group. Furthermore, the analysis indicated that 46% of the individuals receiving Omvoh exhibited an endoscopic response—evidence of visible healing of the intestinal lining—while only 23% in the placebo group achieved similar results.

Omvoh operates through a novel mechanism by specifically targeting interleukin-23p19 (IL-23p19), a cytokine involved in the inflammatory pathways that underpin conditions like Crohn’s disease. By selectively inhibiting IL-23p19, Omvoh effectively mitigates inflammation within the gastrointestinal tract, providing a new option for patients suffering from this challenging chronic disease.

The approval of Omvoh is particularly significant for the approximately 1 million individuals in the United States who are living with Crohn’s disease, a chronic condition characterized by inflammation of the digestive tract that often leads to severe discomfort and a range of complications. Michael Osso, president and CEO of the Crohn’s & Colitis Foundation, highlighted the importance of this advancement, stating, “This approval is meaningful for adult patients with Crohn’s disease, who now have more treatment options available.” Such options are crucial, as they can enhance the quality of life for those navigating the complexities of this disease.

Eli Lilly’s strategic expansion into the inflammatory bowel disease market aligns the company with other major pharmaceutical leaders, including AbbVie and Johnson & Johnson, who have long been at the forefront of IBD therapeutics. In a move to further solidify its position in this arena, Lilly acquired Morphic Holding in 2024 for an impressive $3.2 billion. This acquisition was aimed at gaining access to Morphic’s innovative experimental oral IBD treatment, indicative of Lilly’s commitment to developing more convenient dosing alternatives that could increase patient adherence compared to traditional injectable therapies.

With the recent FDA approval of Omvoh for both Crohn’s disease and ulcerative colitis, patients now have the opportunity to access a treatment that not only aims for long-term disease control but also addresses crucial symptoms associated with inflammatory bowel diseases. This reflects Eli Lilly’s ongoing commitment to improving health outcomes for individuals affected by these challenging conditions, ultimately striving to enhance the overall quality of life for patients managing inflammatory bowel diseases.