FDA approves Zinplava to reduce CDI recurrence

Merck & Co. Inc. (NYSE:MRK) said FDA approved Zinplava bezlotoxumab to reduce the recurrence of Clostridium difficile infection in high-risk adult patients receiving antibacterial drugs. Merck plans to launch the drug next quarter. The company did not respond to inquiries about its price.

Zinplava is a human mAb targeting C. difficile toxin B ( TcdB). In June, FDA's Antimicrobial Drugs Advisory Committee voted 10-5, with one abstention, that Zinplava was safe and effective to prevent C. difficile recurrence. FDA extended its review of the drug by three months to obtain additional data and analyses from two Phase III studies of Zinplava (see BioCentury Extra, July 21). ...