FDA Approval of Bezlotoxumab in Prevention of Recurrent Clostridium difficile Infection

In October 2016, the U.S. FDA approved bezlotoxumab (Zinplava), a human monoclonal antibody directed against C. difficile toxin B, for use in the prevention of C. difficile infection (CDI) recurrence in patients ≥18 years of age who are receiving treatment for C. difficile infection and are deemed at high risk for recurrent disease. Risk factors include age ≥65 years, use of systemic antibacterial drugs, severe CDI or history of CDI in the previous 6 months, immunocompromised state, and CDI caused by the hypervirulent ribotype strains type 027, 078, or 244. Bezlotoxumab became available for use in February 2017.

Approval was based on two randomized, double-blind, placebo-controlled clinical trials, MODIFY I and MODIFY II (clinicaltrials.gov …