Takeda announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) seeking approval of intravenous ENTYVIO (vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients ages 2 years and older. If approved, ENTYVIO would become the only gut-focused treatment option for this population, underscoring Takeda’s commitment to advancing care for children living with inflammatory bowel disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of 2027.
Takeda noted that children and adolescents diagnosed with UC or Crohn’s disease often face decades of treatment and can develop more extensive disease than adults, yet therapeutic options for younger patients have historically been limited. The company believes ENTYVIO’s well-established efficacy and safety profile in adults, supported by more than a dozen years of scientific and clinical data, can help address the need for additional treatments that achieve clinical remission in pediatric UC and Crohn’s disease.
The sBLA and a parallel marketing authorization application submitted to the European Medicines Agency are supported by data from two randomized, double-blind, multicenter Phase 3 pediatric trials in patients ages 2 to 17 years: the KEPLER study in UC and the ongoing WEBB study in Crohn’s disease. KEPLER evaluated clinical remission at Week 54 among patients who achieved a clinical response after vedolizumab IV induction, while WEBB’s co-primary endpoints are clinical remission and endoscopic response at Week 54. ENTYVIO is already approved for the treatment of moderately to severely active UC and Crohn’s disease in adults, and Takeda plans additional regulatory filings in other markets later this year.
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