BioCentury
ARTICLE | Clinical News

Bezlotoxumab regulatory update

February 1, 2016 8:00 AM UTC

FDA accepted and granted Priority Review to a BLA from Merck for bezlotoxumab to prevent recurrence of Clostridium difficile infection. The PDUFA date is July 23. An MAA for the human mAb targeting C. difficile toxin B ( TcdB) is under EMA review. Last September, the company said bezlotoxumab significantly improved infection recurrence over placebo in 2 Phase III trials, alone and in combination with actoxumab ( MDX-066), a human mAb targeting C. difficile toxin A ( TcdA) (see BioCentury, Sept. 28, 2015). ...