The U.S. Food and Drug Administration has accepted Takeda Pharmaceutical Company's (NYSE: TAK) 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 has set a Prescription Drug User Fee Act goal date in the first quarter of calendar year 2027 for its review. If approved, ENTYVIO would become the first gut-focused treatment option for this pediatric population.

Takeda has also submitted a marketing authorization application to the European Medicines Agency for the same pediatric indication and plans to submit applications in additional markets later this year.

The applications are supported by data from two Phase 3 pediatric trials in patients ages 2 to 17 years: the completed KEPLER study in ulcerative colitis and the ongoing WEBB study in Crohn's disease. The KEPLER study's primary endpoint was clinical remission at Week 54 among patients who achieved clinical response following vedolizumab IV induction, while WEBB had co-primary endpoints of clinical remission and endoscopic response at Week 54.

Approximately 25% of inflammatory bowel disease cases are diagnosed before age 20, according to the company. Children with IBD often develop more extensive disease compared to adults.

ENTYVIO is currently approved for treating moderately to severely active ulcerative colitis and Crohn's disease in adults. The drug has marketing authorization in more than 80 countries for IV administration and in more than 50 countries for subcutaneous administration, with more than 1.9 million patient years of global exposure.