The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, June 9, 2016 meeting of the Antimicrobial Drugs Advisory Committee (AMDAC). The Committee will discuss biologics license application (BLA 761046) for bezlotoxumab for the proposed indication of the prevention of Clostridium difficile (C. diff) infection recurrence. In their briefing materials, Merck specifies the following proposed indication: bezlotoxumab is indicated for the prevention of Clostridium difficile infection (CDI) recurrence in patients 18 years or older receiving antibiotic therapy for CDI.
See the SAC Tracker report