Merck & Co., Inc. (NYSE: 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.
"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.
Full ratings data available on Benzinga Pro.
Do you have ideas for articles/interviews you'd like to see more of on Benzinga? Please email firstname.lastname@example.org with your best article ideas. One person will be randomly selected to win a $20 Amazon gift card!
See more from Benzinga
- Exclusive: Interview With DelMar Pharmaceutical CEO Jeffrey Bacha
- Presidential Merck: 'Jimmy Carter' Oncology Drug Expected To Dominate, Hep C Drug Approved Across EU
© 2016 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.