Osaka, Japan & Cambridge, Mass. — Takeda said the U.S. Food and Drug Administration has accepted for review its supplemental Biologics License Application for intravenous ENTYVIO for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients ages 2 and older.
If approved, ENTYVIO would be the only gut-focused treatment option for those pediatric patients, the company said. The FDA has set a Prescription Drug User Fee Act goal date in the first quarter of calendar year 2027.
ENTYVIO, also known as vedolizumab, is currently approved for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in 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, M.D., Ph.D., senior vice president and head of Takeda’s Gastrointestinal & Inflammation Therapeutic Area Unit.
Ukomadu said treatment options for pediatric patients have historically been limited and that additional therapies are needed to help 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,” Ukomadu said. “We’re confident that, if approved, ENTYVIO IV would contribute to addressing the unmet needs in the treatment of pediatric UC and Crohn’s disease.”
Ulcerative colitis and Crohn’s disease are the two most common forms of inflammatory bowel disease. They are lifelong, relapsing and remitting inflammatory diseases of the gastrointestinal tract. Takeda said about 25 percent of patients are diagnosed with inflammatory bowel disease before age 20, and prevalence among children and adolescents continues to rise globally.
Takeda has also submitted a marketing authorization application to the European Medicines Agency for intravenous ENTYVIO for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients ages 2 and older. The company said it plans to submit applications in additional markets later this year.
The U.S. and European applications are supported by data from two randomized, double-blind, multicenter Phase 3 pediatric trials in patients ages 2 to 17: the KEPLER study in ulcerative colitis 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.
