ENTYVIO (vedolizumab) - (KEPLER)

June 8, 2026: Takeda (TAK) announced the FDA has accepted for review its supplemental BLA for intravenous ENTYVIO (vedolizumab) to treat moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients ages 2 years and older. The FDA set a PDUFA goal date in the first quarter of calendar year 2027.

Takeda also submitted a marketing authorization application to the European Medicines Agency for the same pediatric indications and said it plans to submit applications in additional markets later in 2026.

The sBLA/MAA are supported by two randomized, double-blind, multicenter Phase 3 pediatric trials in patients ages 2–17: KEPLER in ulcerative colitis (NCT04779307; EudraCT 2020-004300-34) and the ongoing WEBB study in Crohn’s disease (NCT04779320; EudraCT 2020-004301-31). KEPLER’s primary endpoint is clinical remission at Week 54 among induction responders; WEBB has co-primary endpoints of clinical remission and endoscopic response at Week 54. ENTYVIO is currently approved for adult UC and Crohn’s disease.