Zinplava bezlotoxumab regulatory update

FDA’s Antimicrobial Drugs Advisory Committee voted 10-5, with 1 abstention, that Merck provided substantial evidence that Zinplava bezlotoxumab is safe and effective to prevent recurrence of Clostridium difficile infection. The human mAb targeting C. difficile toxin B ( TcdB) is under Priority Review, with a July 23 PDUFA date. An MAA for bezlotoxumab is under EMA review.

Panel members expressed concern about the interpretation of the primary endpoint of the Phase III MODIFY I and MODIFY II trials used in the BLA; however, most were convinced that the totality of data supported the treatment’s safety and efficacy. Some committee members recommended limiting Zinplava’s use to high-risk patients and some recommended additional studies to evaluate its safety in patients with congestive heart failure (CHF) and in pediatric patients. ...