FDA extends review of Takeda's vedolizumab for UC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said FDA extended by three months the review of a BLA for Entyvio vedolizumab to treat moderately to severely active ulcerative colitis. The new PDUFA date is May 20; it was Feb. 18. The application is under Priority Review. According to Takeda, at FDA's request the pharma submitted a major amendment to the BLA, including updated proposed labeling. The agency extended the review to allow "time for a full review." A BLA for vedolizumab to treat moderately to severely active Crohn's disease is still under standard review, with a June 18 PDUFA date. ...