Takeda's Application for ENTYVIO IV Accepted by FDA in Pediatric Ulcerative Colitis and Crohn's Disease

MT Newswires Live06-10

Takeda Pharmaceutical (TAK) said late Tuesday the US Food and Drug Administration has accepted for review its supplemental biologics license application for intravenous ENTYVIO for the treatment of moderate to severely active ulcerative colitis and Crohn's disease in pediatric patients aged 2 years and older.

If approved, ENTYVIO would be the only gut-focused treatment option for these patients, the company said.

The FDA has set a Prescription Drug User Fee Act goal date in Q1 2027.

Takeda said it has also submitted a marketing authorization application to the European Medicines Agency for ENTYVIO IV to treat pediatric patients aged 2 years and older.

ENTYVIO is currently approved for the treatment of moderate to severely active UC and Crohn's disease in adults.

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