Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence

FDA grants Priority Review with target action date of 23 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.

“Recurrence is a major challenge with C. difficile infection, one of the most common healthcare-associated infections in US hospitals,” said Dr Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Currently, there are no therapies approved for the prevention of C. difficile infection recurrence. As part of Merck’s commitment to the fight against infectious diseases, we look forward to continuing to work with the FDA and EMA to bring forward this novel medicine for appropriate patients.”

The application for bezlotoxumab is based in part on data from the pivotal MODIFY I and MODIFY II clinical trials. Data from these trials were previously presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 joint meeting.