Merck Has An Upcoming PDUFA Date For Bezlotoxumab

Merck & Co., Inc. MRK announced it has an upcoming PDUFA date on October 23. The FDA has accepted for review Merck's Biologics License application for Bezlotoxumab, an investigational antitoxin for the prevention of Clostridium difficile (C. Diff.) infection recurrence.

"Recurrence is a major challenge with C. difficile infection, one of the most common healthcare-associated infections in U.S. hospitals," said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories.

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"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," Baynes added.

The FDA granted Priority Review for bezlotoxumab on July 23, 2016.

Merck traded down 1 percent Friday.

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