Eli Lilly’s Omvoh (mirikizumab) has demonstrated its capacity to keep patients free from corticosteroids and promote long-term clinical remission in Crohn’s disease.
This is evidenced by the results of the Phase III VIVID-2 open-label extension (OLE) study (NCT04232553), which revealed that 92.4% of patients who achieved an endoscopic response at one year remained in clinical remission at the three-year mark following continuous monthly treatment with Omvoh. This rate remained consistent with two-year data released in 2025, where 92.9% of patients given the drug achieved remission.
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Within the one-year responder cohort, 91.2% achieved this milestone free of corticosteroids. In this study, patients were considered to be in clinical remission if they achieved a total Crohn’s disease activity index (CDAI) score of below 150.
After three years, Omvoh also triggered bowel urgency remission in 71.7% of patients, which was 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’s long-term safety and tolerability was consistent with the drug’s known profile, with the most common adverse events (AEs) being Covid-19, nasopharyngitis and upper respiratory tract infection.
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By GlobalDataThis builds on the positive data from the Phase III VIVID-1 study (NCT03926130), in which Omvoh bested the efficacy of Johnson & Johnson’s (J&J) blockbuster Crohn’s therapy, Stelara (NCT03926130).
Lilly seeks a bigger slice of the Crohn’s market
While Lilly has seen notable sales success from its obesity portfolio, the company is now looking to gain a stronger footing in the inflammatory disease market through Omvoh and plaque psoriasis drug, Taltz (ixekizumab).
Omvoh first gained approval from the US Food and Drug Administration (FDA) in ulcerative colitis (UC) back in 2023. Since then, it has also got the agency’s blessing for use in Crohn’s disease in January 2025. GlobalData, parent company of Clinical Trials Arena, forecasts that the drug will cross the line into blockbuster sales territory by 2031.
However, within the inflammatory bowel disease (IBD) space, Lilly will have to fend off strong competition from dominant drugs such as AbbVie’s IL-23 blocker Skyrizi (risankizumab), which generated sales of $17.5bn in 2025.
Omvoh will also have to come up against J&J’s portfolio of drugs – including Stelara and its legacy therapeutic, Tremfya (guselkumab). While Stelera’s sales are now experiencing biosimilar erosion due to its loss of market exclusivity, Tremfya is slated to be a big seller for J&J, with GlobalData forecasting that the drug will bring in $9bn in sales during 2031.
According to a GlobalData report, 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.
