Takeda: FDA accepts sBLA for IV ENTYVIO in pediatric UC and Crohn’s
- FDA has accepted Takeda’s sBLA for intravenous vedolizumab (ENTYVIO) for pediatric UC and Crohn’s in patients aged 2 years and older.
- If approved, ENTYVIO would be the only gut-focused treatment option for these pediatric patients.
- The FDA set a PDUFA goal date in the first quarter of 2027.
- sBLA is supported by two Phase 3 pediatric trials: KEPLER (UC) and WEBB (Crohn’s) with Week 54 primary/co-primary endpoints.
Regulatory update
The U.S. Food and Drug Administration has accepted for review Takeda’s supplemental Biologics License Application 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 Prescription Drug User Fee Act goal date in the first quarter of calendar year 2027.
Clinical evidence
The submission is supported by two randomized, double-blind, multicenter Phase 3 pediatric trials in patients aged 2–17: KEPLER for ulcerative colitis and WEBB for Crohn’s disease. KEPLER’s primary endpoint was clinical remission at Week 54 among patients who achieved a clinical response following vedolizumab IV induction. WEBB’s co-primary endpoints were clinical remission and endoscopic response at Week 54.
Market positioning and next steps
If approved, ENTYVIO IV would be the only gut-focused treatment option for children aged two and older with moderately to severely active UC or Crohn’s. Takeda has also submitted a marketing authorization application to the European Medicines Agency and plans additional regulatory submissions in other markets later this year. ENTYVIO is already approved for these indications in adults.
Source: Takeda
