Lilly’s Omvoh’s Two-Year Journey Confirms Lasting Impact on Crohn’s Disease Treatment

Eli Lilly and Company reported results from the VIVID-2 open-label extension study. The findings showed that most patients with moderately to severely active Crohn’s disease who received Omvoh (mirikizumab-mrkz) continuously for two years achieved sustained clinical and endoscopic improvements. This included 43.8% of patients with prior biologic treatment failure.

Omvoh Targeting IL-23p19 to Reduce Intestinal Inflammation and Sustain Outcomes in Phase 3 Trials

Omvoh reduces inflammation in the gastrointestinal tract by targeting interleukin-23p19 (IL-23p19), a protein that plays a key role in intestinal inflammation. Participants in the Phase 3 VIVID-1 study who received Omvoh and achieved an endoscopic response after one year continued maintenance treatment in the VIVID-2 extension study. An observed case analysis showed sustained clinical and endoscopic outcomes after two years of continuous treatment, including one year in VIVID-1.

In the VIVID-1 study, 92.9% of patients who were in clinical remission after one year remained in remission after two years, as measured by the Crohn’s Disease Activity Index (CDAI).  On the other hand the VIVID-2 study, 87.6% of patients maintained an endoscopic response, meaning their intestinal lining showed visible healing with at least a 50% improvement from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD). 

“Lilly is setting a high bar for sustained and durable treatment response for patients living with the profound impact of inflammatory bowel disease,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “These results build on the body of evidence that demonstrates Omvoh’s ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic and histologic outcomes.”

44 Countries and the FDA Approve Omvoh as Clinical Trials Continue for Crohn’s Disease and UC

The U.S. Food and Drug Administration (FDA) approved Omvoh in January 2025 for treating moderately to severely active Crohn’s disease in adults. In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending its approval for the same condition. 

Regulators have approved Omvoh in 44 countries for treating moderately to severely active ulcerative colitis (UC) in adults. This treatment is the first and only IL-23p19 antagonist proven to provide long-term, multi-year efficacy and safety for both Crohn’s disease and UC. Ongoing clinical trials are further evaluating its effectiveness, including studies on long-term safety in pediatric and adult patients. 

Researchers are developing and approving several other IL-23p19 inhibitors for inflammatory bowel diseases. Skyrizi (risankizumab) by AbbVie is approved for Crohn’s disease and is undergoing studies for ulcerative colitis (UC). Tremfya (guselkumab) by Janssen, currently used for psoriasis and psoriatic arthritis, is in clinical trials for both Crohn’s disease and UC. While these therapies target the same pathway, they differ in their clinical data, regulatory approvals, and long-term efficacy profiles.

“Many people living with Crohn’s disease have tried available therapies without success or have experienced a loss of efficacy with their treatment,” said Edward Barnes, M.D., MPH, Associate Professor of Medicine in the Division of Gastroenterology & Hepatology, Co-Director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill. “These positive, multi-year data can give health care providers confidence that Omvoh may help their patients achieve and maintain long-term outcomes, including intestinal healing.”

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Denisse Sandoval