Lilly's Omvoh met Phase 3 pediatric UC primary endpoint; company to seek pediatric label expansion

Eli Lilly reported on Oct. 19, 2026 that in SHINE‑2 — a Phase 3, multicenter, single‑arm, open‑label study in pediatric patients with moderately to severely active ulcerative colitis — 50% of Week‑12 responders achieved clinical remission at Week 52, meeting the study’s primary endpoint. Lilly’s news release also gives the primary endpoint definition used in SHINE‑2. (Source: Lilly investor news release, 2026‑10‑19: https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-meets-primary-endpoint-clinical)

Lilly reported additional one‑year results among induction responders: 71.2% achieved symptomatic remission and 50% achieved corticosteroid‑free clinical remission without surgery; 81% of patients achieved clinical response to Omvoh induction at Week 12. The company said the safety profile through Week 52 was consistent with adult data, listing common treatment‑emergent adverse events and reporting no deaths, malignancies, opportunistic infections or growth‑related safety concerns. Lilly said the SHINE‑2 results were presented as a late‑breaking oral presentation at UEG Week 2026. (Source: Lilly investor news release, 2026‑10‑19)

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