Takeda Reports 47% of Patients Met Primary Endpoint in Entyvio Trial

By Elias Schisgall

Takeda said data from a Phase 3 trial showed its Entyvio treatment provides the possibility of achieving clinical remission in pediatric patients with a form of gastrointestinal tract disease.

The pharmaceutical company said Thursday that about 47% of patients between the ages of two and 17 reached the primary endpoint of clinical remission after 54 weeks. About 35% reached clinical remission after 14 weeks, the secondary endpoint of the study.

Entyvio, the brand name for vedolizumab, is designed to treat moderate to severe active ulcerative colitis, a disease involving chronic inflammation of the GI tract.

"We observed clinically meaningful improvements with vedolizumab in an especially difficult-to-treat patient population--children and adolescents who had failed on the current standard of care, including conventional therapies and/or tumor necrosis factor (TNF) antagonists," MNGI Digestive Health gastroenterologist Ramalingam Arumugam, one of the investigators on the study, said.

Takeda said the safety profile of the treatment in children was generally consistent with its safety profile in adult patients.

The company plans to submit marketing applications in the U.S. and the European Union for the intravenous formulation of the drug in children and adolescents.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

February 19, 2026 12:58 ET (17:58 GMT)