Eli Lilly reports 50% pediatric ulcerative colitis remission

• Eli Lilly reported that Omvoh met the primary endpoint in its Phase 3 SHINE-2 study, with 50% of Week 12 responders achieving clinical remission at Week 52.
• Serious adverse events occurred in 6.3% of patients through Week 52, with none considered treatment-related and no new safety signals identified.
• Lilly plans global regulatory submissions seeking to expand Omvoh's approved use to children aged 6–17 with ulcerative colitis.

Eli Lilly (NYSE:LLY) reported that Omvoh met its Phase 3 SHINE-2 primary endpoint, with 50% of 52 pediatric responders achieving clinical remission at Week 52.

The study recorded an 81% clinical response rate at Week 12, but used a historical adult placebo benchmark rather than a concurrent control group.

The single-arm, open-label study evaluated Omvoh in children aged 6–17 with ulcerative colitis, assessing remission after 52 weeks of treatment.

Among Week 12 responders, 71.2% achieved symptomatic remission, 50% achieved corticosteroid-free clinical remission without surgery, and 44.2% reached endoscopic remission at Week 52.

Lilly plans global regulatory submissions for a potential pediatric label expansion.

Four patients, representing 6.3%, experienced serious adverse events, while two patients, or 3.2%, discontinued treatment due to ulcerative colitis flares.

Omvoh is already approved for adults with ulcerative colitis and Crohn's disease, with previous adult studies supporting its use in inflammatory bowel disease.