Bezlotoxumab regulatory update

Merck said FDA extended the PDUFA date to Oct. 23 from July 23 for a BLA for Zinplava bezlotoxumab to prevent Clostridium difficile infection recurrence. The company said FDA requested additional data and analyses from the Phase III MODIFY I and MODIFY II trials of the candidate. Merck declined to disclose additional details about FDA’s request. The BLA had been granted Priority Review.

Last month, FDA’s Antimicrobial Drugs Advisory Committee voted 10-5, with 1 abstention, that Merck provided substantial evidence that Zinplava is safe and effective to prevent recurrence of C. difficile infection. Panel members expressed concern about the interpretation of the primary endpoint of the MODIFY trials; however, most were convinced that the totality of data supported the treatment’s safety and efficacy (see BioCentury, June 20). ...