Priority Review for Merck's bezlotoxumab

Merck & Co Inc. (NYSE:MRK) said FDA accepted for filing and granted Priority Review to a BLA for bezlotoxumab ( MK-6072) to treat recurrent Clostridium difficile infection. Its PDUFA date is July 23.

Merck said EMA is reviewing an MAA for the human mAb targeting C. difficile toxin B ( TcdB). In September 2015, the company said bezlotoxumab significantly improved infection recurrence over placebo in two Phase III trials, alone and in combination with actoxumab ( MDX-066) (see BioCentury Extra, Sept. 21, 2015). ...