By VETTAPHARMA reporter – Derek Roche: Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for intravenous 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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2027.
If approved, ENTYVIO would become the only gut-focused treatment option for children and adolescents aged 2 years and older with moderately to severely active UC or Crohn’s disease. Takeda said the filing reflects its commitment to addressing unmet treatment needs in pediatric inflammatory bowel disease (IBD), where therapeutic options remain limited despite the lifelong burden of disease.
Ulcerative colitis and Crohn’s disease are the two most common forms of IBD. Approximately 25% of patients are diagnosed before the age of 20, and disease prevalence among children and adolescents continues to increase globally. Children with IBD frequently develop more extensive disease than adult patients, creating a need for effective long-term treatment strategies.
The regulatory submission is supported by data from two Phase 3 pediatric studies evaluating vedolizumab in patients aged 2 to 17 years. The KEPLER study in ulcerative colitis was a randomized, double-blind, multicenter trial that evaluated clinical remission at Week 54 among patients who achieved a clinical response following intravenous induction therapy. The ongoing WEBB study in Crohn’s disease is assessing co-primary endpoints of clinical remission and endoscopic response at Week 54.
Takeda also disclosed that it has submitted a marketing authorization application to the European Medicines Agency for the same pediatric indications and plans to pursue additional regulatory submissions in other markets later in 2026.
ENTYVIO is currently approved for adult patients with moderately to severely active ulcerative colitis and Crohn’s disease. According to Takeda, the product has accumulated more than 1.9 million patient-years of exposure globally and has marketing authorization in more than 80 countries for intravenous administration and more than 50 countries for subcutaneous administration.
Quick FAQs
1. What Is ENTYVIO?
ENTYVIO (vedolizumab) is a biologic therapy that selectively targets the gastrointestinal tract and is currently approved for treating moderately to severely active ulcerative colitis and Crohn’s disease in adults.
2. What Happened?
The FDA accepted Takeda’s supplemental Biologics License Application for intravenous ENTYVIO in pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis or Crohn’s disease and assigned a PDUFA target date in the first quarter of 2027.
3. What Is The Study Program Supporting The Filing?
The submission is supported by the Phase 3 KEPLER study in pediatric ulcerative colitis and the ongoing Phase 3 WEBB study in pediatric Crohn’s disease, both enrolling patients aged 2 to 17 years.
4. What Is Pediatric Inflammatory Bowel Disease?
Pediatric inflammatory bowel disease includes ulcerative colitis and Crohn’s disease diagnosed in children and adolescents. Around one-quarter of IBD cases are diagnosed before age 20.
5. What Were the Key Clinical Endpoints?
KEPLER evaluated clinical remission at Week 54 following response to vedolizumab induction therapy, while WEBB is evaluating co-primary endpoints of clinical remission and endoscopic response at Week 54.
6. Why Is This Important?
If approved, ENTYVIO could become the first and only gut-focused treatment for pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis or Crohn’s disease, potentially expanding treatment options for a population with significant unmet medical needs.
