Takeda Pharmaceutical Company Ltd. (TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application or 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) date in the first quarter of calendar year 2027.
ENTYVIO or Vedolizumab is a biologic therapy and is FDA-approved for the treatment of moderately to severely active UC and Crohn's disease in adults.
Takeda has also submitted a marketing authorisation application (MAA) to the European Medicines Agency for ENTYVIO IV for pediatric patients and plans to submit applications in additional markets later this year.
The SBLA and MAA are supported by data from two randomised, double-blind, multicenter Phase 3 paediatric trials in patients aged 2 to 17 years, dubbed the KEPLER study in UC and the ongoing WEBB study in Crohn's disease.
Ulcerative colitis (UC) and Crohn's disease, the two most common forms of inflammatory bowel disease (IBD), are lifelong inflammatory conditions of the digestive tract. UC is limited to the colon and rectum, whereas Crohn's disease can affect any part of the gastrointestinal tract and may involve deeper tissue layers. (Source: Mayo Clinic)
For the fiscal year ended March 31, 2026, global ENTYVIO revenue increased 4.8% to 958.0 billion Japanese Yen from 914.1 billion Japanese Yen a year earlier.
TAK has traded between $12.99 and $18.90 over the last year. The stock closed Tuesday's trade at $15.72, down 0.13%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.