Eli Lilly reports 50% remission in pediatric ulcerative colitis trial of Omvoh
Eli Lilly announced that its Phase 3 SHINE‑2 study of Omvoh (mirikizumab‑mrkz) in children with moderately to severely active ulcerative colitis met its primary endpoint, with half of the responders achieving clinical remission at one year. The trial showed an 81% clinical‑response rate at Week 12 and a 73.1% sustained response at Week 52. Lilly said it will submit the data to global regulators to seek a pediatric label extension for Omvoh, which is already approved for adult ulcerative colitis and Crohn’s disease.
Why it matters
If regulators approve the pediatric indication, Omvoh could open a new market segment for Lilly, adding to its immunology franchise and potentially boosting future revenue (Lilly’s statement). The trial’s safety profile was consistent with adult data, reducing concerns about new safety risks ().
Key facts
- 181% of patients achieved clinical response at Week 12. stocktitan.net
- 250% of responders achieved clinical remission at Week 52, meeting the primary endpoint. prnewswire.com
- 373.1% of patients maintained clinical response at Week 52. prnewswire.com
- 4The study enrolled 63 participants, of whom 52 entered the maintenance period as responders. stocktitan.net
- 5Safety through Week 52 was consistent with the adult profile, with no new safety signals identified. prnewswire.com
- 6Lilly plans to submit the data to global regulators to seek a pediatric label expansion for Omvoh. stocktitan.net
Summary written by AlphAI AI Desk from 8 of 8 sources. Not investment advice. Figures are as stated by the linked sources.