FDA accepts Takeda's sBLA for intravenous Entyvio
The US Food and Drug Administration (FDA) has accepted for review Japan’s largest drugmaker Takeda’s (TYO: 4502) 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 aged 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.
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