Merck announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for bezlotoxumab for the prevention of Clostridium difficile (C. difficile) infection recurrence.
The BLA submission is based in part on data from the pivotal MODIFY I and MODIFY II clinical trials. Findings from these studies were previously presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 joint meeting.
The FDA set a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016 to complete the review.
Bezlotoxumab, an investigational antitoxin designed to neutralize C. difficile toxin B, is given in conjunction with standard of care antibiotic treatments for C. difficile infection.
For more information call (800) 672-6372 or visit Merck.com.