FDA accepts Takeda’s sBLA for ENTYVIO in pediatric UC and Crohn’s disease, with a PDUFA decision expected in Q1 2027 to expand gut‑selective IBD care.
Written By: Kalyani Boharapi,
M. Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has accepted Takeda’s supplemental Biologics License Application (sBLA) for intravenous ENTYVIO (vedolizumab) to treat moderately to severely active ulcerative colitis (UC) and Crohn’s disease in children aged two years and older. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2027, consistent with the standard 10-month review timeline.
Expanding Options in Pediatric IBD
If approved, ENTYVIO would become the first gut-selective therapy available for pediatric patients with UC or Crohn’s disease. Pediatric inflammatory bowel disease (IBD) remains an area of significant unmet need, with approximately one-quarter of all IBD diagnoses occurring before age 20. Children with IBD often develop more extensive and aggressive disease than adults and may require decades of ongoing treatment and disease management.
Current treatment options largely rely on systemic biologics, highlighting the potential value of a gut-selective approach for younger patients.
Targeted Mechanism of Action
Vedolizumab is a monoclonal antibody that binds to the α4β7 integrin, blocking immune-cell trafficking into the gastrointestinal tract. By focusing its activity within the gut, ENTYVIO provides targeted control of intestinal inflammation while limiting systemic immune effects.
The therapy is currently the only gut-selective biologic approved for adults with ulcerative colitis and Crohn’s disease and has accumulated more than a decade of clinical experience across global markets.
Phase 3 Trials Underpin Filing
The pediatric submission is supported by two randomized, double-blind, multicenter Phase 3 studies in patients aged 2 to 17 years.
The KEPLER trial (NCT04779307) evaluated children and adolescents with ulcerative colitis, with the primary endpoint of clinical remission at Week 54 among patients who achieved a clinical response following vedolizumab induction therapy. The ongoing WEBB study (NCT04779320) is evaluating pediatric Crohn’s disease and uses co-primary endpoints of clinical remission and endoscopic response at Week 54.
Takeda said data from the studies supported the efficacy and safety profile of vedolizumab in pediatric patients and formed the basis of both the U.S. and European regulatory submissions.
Building on Established Clinical Experience
ENTYVIO is approved for adults with moderately to severely active UC and Crohn’s disease and is available in intravenous and subcutaneous formulations across numerous global markets. With more than 1.9 million patient-years of global exposure, ENTYVIO has accumulated extensive long-term clinical and real-world experience.
According to Chinwe Ukomadu, M.D., Ph.D., Senior Vice President and Head of Takeda’s Gastrointestinal and Inflammation Therapeutic Area Unit, children and adolescents with UC and Crohn’s disease represent one of the most challenging populations in gastroenterology due to limited treatment options and the need for long-term disease control. She noted that ENTYVIO’s well-established efficacy and safety profile in adults provides a strong foundation for its potential use in younger patients.
FDA Decision Expected in Early 2027
Beyond the U.S. filing, Takeda has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval of intravenous ENTYVIO for pediatric UC and Crohn’s disease. The company also plans to submit applications in additional markets later this year.
A positive FDA decision in 2027 would mark ENTYVIO’s first pediatric indication, expanding treatment options for children and adolescents living with IBD while extending the therapy’s reach into a patient population with substantial unmet medical need.
Reference
U.S. FDA Accepts Takeda sBLA for Review in Pediatric UC and Crohn’s Disease
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.