FDA Will Review BLA for Merck’s Bezlotoxumab

Merck announced on Jan. 27, 2016 that FDA will review the biologics license application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

There are currently no therapies indicated to prevent C. difficile infection recurrence. Roy Baynes, PhD, senior vice president of clinical development at Merck, said in a statement that C. difficile infection is “one of the most common healthcare-associated infections in US hospitals.”

FDA granted priority review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016. The company also has filed a marketing authorization application for bezlotoxumab with the European Medicines Agency (EMA) that is currently under review.