Late-stage trial meets primary endpoint! Eli Lilly (LLY.US) plans to expand Omvoh indication for pediatric ulcerative colitis treatment

Eli Lilly (LLY.US) announced on Monday that it plans to seek to expand the indication for its Omvoh injection for the treatment of pediatric ulcerative colitis after a late-stage trial in pediatric patients with the disease succeeded. Ulcerative colitis is an inflammatory disease involving the colon. Eli Lilly, citing one-year trial results, said its Phase 3 SHINE-2 study met its primary endpoint50% of patients who responded to Omvoh achieved clinical remission at week 52. The study enrolled a total of 63 patients aged 4 to 17 with moderately to severely active ulcerative colitis; the week 52 results came from 52 of those patients aged 6 to 17 who were identified as clinical responders. Eli Lilly said the safety profile of Omvoh in the study was consistent with the tolerability profile already established for the drug in adult patients. However, four subjects experienced serious adverse events unrelated to the investigational drug, and two other patients withdrew from the study after experiencing a relapse of ulcerative colitis. Omvoh is currently approved in the United States for the treatment of adults with active ulcerative colitis and Crohn's disease. Eli Lilly plans to submit these study results to global regulatory authorities to advance the expansion of Omvoh's indication for the treatment of pediatric ulcerative colitis.