U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 milest