Pediatric patients with inflammatory bowel disease represent one of the most therapeutically underserved populations in gastroenterology, and Takeda's submission of a supplemental Biologics License Application (sBLA) to the US FDA for Entyvio (vedolizumab) in children as young as two years old marks the first filing for a gut-selective biologic in this age group. The US FDA has accepted the application for review, with a Prescription Drug User Fee Act goal date set in Q1 2027.
The sBLA seeks approval of intravenous Entyvio for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in pediatric patients aged 2 to 17 years. The filing covers the IV formulation only, consistent with the induction and maintenance regimen studied in the supporting trials. Takeda said it has also submitted a marketing authorization application to the European Medicines Agency for the same indication and patient population, with additional global submissions planned.
The application is supported by data from two randomized, double-blind, multicenter Phase III pediatric trials. The KEPLER study enrolled patients aged 2 to 17 years with moderately to severely active UC, with the primary endpoint of clinical remission at Week 54 among patients who achieved clinical response following IV induction. The WEBB study, which evaluated the same age group in Crohn's disease, remains ongoing and used co-primary endpoints of clinical remission and endoscopic response at Week 54.