Merck’s Biologics License Application for bezlotoxumab approved

The FDA has accepted Merck's Biologics License Application for bezlotoxumab | File photo

Merck announced this week that the Food and Drug Administration (FDA) has accepted its Biologics License Application for bezlotoxumab for review.

Bezlotoxumab is an experimental antitoxin designed to inhibit the recurrence of the Clostridium difficile (C. difficile) infection. The FDA also gave the product an action date of July 23 under the Prescription Drug User Fee Act. The European Medicines Agency has also received a marketing authorization application from Merck that is currently being reviewed.

C. difficile is among the most common recurring infections contracted in United States hospitals associated with health care. Bezlotoxumab can counteract C. difficile’s toxin B, which damages the gut wall and causes inflammation.

Bezlotoxumab’s application centers around data from the drug’s MODIFY I and MODIFY II clinical trials. The data recorded during these trials was presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection 2015 collaborative conference.

The FDA has not approved any other products to fight the infection. 

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