FDA panel backs Merck anti-infective Zinplava

FDA's Antimicrobial Drugs Advisory Committee voted 10-5, with one abstention, that Merck & Co. Inc. (NYSE:MRK) provided substantial evidence that Zinplava bezlotoxumab is safe and effective to prevent Clostridium difficile infection recurrence in adults. The PDUFA date for Zinplaya's BLA is July 23.

Panel members expressed concern about the interpretation of the primary endpoint of the Phase III MODIFY I and MODIFY II studies 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 and in pediatric patients. ...