FDA extends Zinplava review, requests more data

Merck & Co. Inc. (NYSE:MRK) said FDA extended its review of a BLA for Zinplava bezlotoxumab ( MK-6072) to prevent Clostridium difficile infection recurrence and requested additional data and analyses from the company's Phase III MODIFY I and MODIFY II studies of the candidate.

Merck said Zinplava's PDUFA date was moved to Oct. 23 from July 23. The BLA had been granted Priority Review. Merck declined to disclose additional details about FDA's request. ...