Lilly’s Omvoh Outperforms J&J’s Stelara in Phase III Crohn’s Disease Trial

Trial Results:
The Phase III VIVID-1 trial showed that Eli Lilly's Omvoh (mirikizumab) was superior to Johnson & Johnson's Stelara (ustekinumab) in treating Crohn's disease, with 58.2% of patients achieving histologic response with Omvoh compared to 48.8% with Stelara at 52 weeks.

Market Competition:
Omvoh faces competition from established drugs like AbbVie's Humira and J&J's Stelara, which generated $6.9 billion and $10.8 billion in global sales last year, respectively.

Regulatory Status:
Omvoh is approved for ulcerative colitis (UC) but not yet for Crohn's disease. Lilly has filed for approval with multiple global regulatory health authorities, including the FDA.

Future Projections:
GlobalData forecasts Omvoh sales to trail behind J&J's Tremfya, with expected global sales of $1.2 billion and $7.7 billion in 2029, respectively.

Safety Profile:
The overall safety profile of Omvoh in patients with moderately to severely active Crohn's disease was consistent with its known safety profile in UC patients, with common adverse events including COVID-19, anemia, arthralgia, headache, and injection site reactions.

Pediatric Trials:
Lilly is evaluating Omvoh for IBD in pediatric patients in three Phase III trials (NCT04844606, NCT05509777, and NCT05784246).