Phase 3 trial meets primary endpoint! Eli Lilly (LLY.US) plans to expand Omvoh's indication for the treatment of pediatric ulcerative colitis

According to Golden Ten Data APP, Eli Lilly (LLY.US) announced on Monday that following the successful completion of a late-stage trial of Omvoh injections for children with ulcerative colitis, the company plans to seek to expand the indications for this therapy for intestinal diseases.

Ulcerative colitis is an inflammatory disease that affects the colon. Eli Lilly cited year-long trial results, stating that its phase 3 SHINE-2 study achieved its primary endpoint—among patients who responded to Omvoh, 50% achieved clinical remission at week 52. The study included a total of 63 patients aged between 4 and 17 with moderately to severely active ulcerative colitis; the results for week 52 were based on 52 clinical responders aged 6 to 17.

Eli Lilly stated that the safety profile of Omvoh in this study was consistent with the established tolerability characteristics in adult patients. However, four subjects experienced serious adverse events unrelated to the study drug, and two patients withdrew from the study after experiencing a relapse of ulcerative colitis.

Omvoh is currently approved in the United States for the treatment of active ulcerative colitis and Crohn's disease in adult patients. Eli Lilly plans to submit these study results to global regulatory agencies in order to promote the expansion of Omvoh's indications for treating ulcerative colitis in children.