Omvoh Maintains 91% Steroid-Free Remission in Crohn's Disease Through Three Years

Eli Lilly's Omvoh (mirikizumab-mrkz) demonstrated durable efficacy through three years in adults with moderately to severely active Crohn's disease, according to new long-term data from the Phase III VIVID-2 open-label extension study (NCT04232553). Among patients who achieved an endoscopic response at one year with Omvoh in the Phase III VIVID-1 clinical trial, 92.4% remained in clinical remission at the three-year mark following continuous monthly treatment, and 91.2% achieved this milestone free of corticosteroids.

Clinical remission was defined as a total Crohn's Disease Activity Index (CDAI) score of below 150. The three-year remission rate remained consistent with two-year data released in 2025, where 92.9% of patients given the drug achieved remission.

After three years, Omvoh also triggered bowel urgency remission in 71.7% of patients, classified as a score of two or lower on the urgency numeric rating scale (UNRS). In addition, 82.1% of patients treated monthly with the drug sustained a ≥3-point UNRS reduction at three years.

The interleukin-23 subunit alpha (IL-23p19) inhibitor was also found to provide a sustained anti-inflammatory effect, as patients experienced a continual decrease in inflammatory biomarkers like faecal calprotectin and C-reactive protein. Omvoh now stands alone as the only IL-23p19 inhibitor to show strong and durable efficacy with simple, consistent monthly dosing over four years in ulcerative colitis and three years in Crohn's disease.

Additional data presented from the Phase III VIVID-1 clinical trial showed Omvoh-treated patients experienced minimal hospitalizations and surgeries. Omvoh reduced Crohn's disease-related hospitalizations and/or surgeries by nearly half versus placebo in the first 12 weeks (incidence rate: 16.9 vs. 30.9 per 100 patient-years), and by nearly 70% during weeks 12 to 52 (4.5 vs. 14.0).

Omvoh's long-term safety and tolerability was consistent with the drug's known profile. Common adverse events reported from the end of year one through the end of year three (≥5% of Omvoh-treated patients who achieved endoscopic response at one year) included COVID-19, nasopharyngitis, and upper respiratory tract infection.

Omvoh first gained approval from the US Food and Drug Administration (FDA) in ulcerative colitis back in 2023, and received the agency's approval for use in Crohn's disease in January 2025. Omvoh is approved for adults with moderate to severe active ulcerative colitis and Crohn's disease in 47 countries globally. The drug is forecasted to cross the line into blockbuster sales territory by 2031.

Within the inflammatory bowel disease space, Omvoh will face competition from dominant drugs such as AbbVie's IL-23 blocker Skyrizi (risankizumab), which generated sales of $17.5bn in 2025. Drug sales within Crohn's disease in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, China, and Japan) will reach $13.8bn in 2032.

Outcomes from the VIVID-1, VIVID-2 and LUCENT-3 trials were presented at the 2026 Congress of the European Crohn's and Colitis Organisation (ECCO) in Stockholm.