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News|Articles|January 28, 2016
FDA Will Review BLA for Merck’s Bezlotoxumab
Author(s)Pharmaceutical Technology Editors
On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.
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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.
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