U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease
If approved, ENTYVIO would be the only gut-focused treatment for patients two years and older with moderately to severely active ulcerative colitis (UC) or Crohn's disease
Potential for ENTYVIO to address pediatric treatment gaps, reflecting Takeda’s commitment to advancing options where unmet treatment needs remain
Takeda (TSE:4502/NYSE:TAK) today announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for intravenous (IV) 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 be the only gut-focused treatment option for these patients. This milestone reflects Takeda's deep commitment to this patient community and its role in advancing care and addressing unmet needs in UC and Crohn's. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027.
“A child or teen diagnosed today with UC or Crohn’s disease has decades of medical treatment ahead and represents one of the most challenging to treat patient populations in pediatric gastroenterology. Yet, historically, therapeutic options for this age group have been limited,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit. “There is a need for additional treatments that can achieve clinical remission. The efficacy and safety profile of ENTYVIO is well-established in adults with more than a dozen years of scientific study and clinical data. We’re confident that, if approved, ENTYVIO IV would contribute to addressing the unmet needs in the treatment of pediatric UC and Crohn’s disease.”
