Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted for review its 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 ages 2 years and older. If approved, ENTYVIO would be the only gut-focused treatment option for these patients, addressing unmet needs in pediatric gastroenterology. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027.

The sBLA submission is supported by data from two randomized, double-blind, multicenter Phase 3 pediatric trials: the KEPLER study in UC and the ongoing WEBB study in Crohn's disease. The primary endpoint for KEPLER was clinical remission at Week 54 among patients who achieved a clinical response following vedolizumab IV induction, while WEBB had co-primary endpoints of clinical remission and endoscopic response at Week 54.

Regulatory Submissions and Trial Details

Takeda has also submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV for the same pediatric indication and plans to submit applications in additional markets later this year. The following table outlines the key clinical trials supporting these submissions.

Clinical Context and Executive Commentary

UC and Crohn's disease are lifelong, relapsing, remitting, inflammatory diseases of the gastrointestinal tract. In approximately 25 percent of patients, inflammatory bowel disease (IBD) is diagnosed before age 20, and its prevalence among children and adolescents continues to rise globally. Children with IBD often develop more extensive disease compared to adults.

"A child or teen diagnosed today with UC or Crohn's disease has decades of medical treatment ahead and represents one of the most challenging to treat patient populations in pediatric gastroenterology," said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit. "There is a need for additional treatments that can achieve clinical remission. The efficacy and safety profile of ENTYVIO is well-established in adults with more than a dozen years of scientific study and clinical data."

ENTYVIO is currently approved for the treatment of moderately to severely active UC and Crohn's disease in adults. It is a biologic therapy that specifically binds to the α4β7 integrin and blocks its interaction with MAdCAM-1, which is mainly expressed on gut endothelial cells. Marketing authorization has been granted in more than 80 countries for ENTYVIO IV and in more than 50 countries for ENTYVIO SC.