FDA accepts Merck's application for C. difficile infection reoccurrence prevention drug
Merck is also working through the European Medicines Agency (EMA) review process and has filed a marketing authorization application with the agency for bezlotoxumab.
“Recurrence is a major challenge with C. difficile infection, one of the most common health care-associated infections in U.S. hospitals,” Dr. Roy Baynes, Merck Research Laboratories senior vice president of clinical development, said. “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.”
Some of the data presented in the application comes from the MODIFY I and MODIFY II clinical trials, which were presented at the 2015 joint meeting of the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC).
In addition to accepting Merck’s BLA, the FDA granted bezlotoxumab priority review and has given the drug a Prescription Drug User Fee Act (PDUFA) action date of July 23.