Merck announced that the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-5 recommending the approval of Zinplava (bezlotoxumab) for the prevention of Clostridium difficile (C. difficile) infection recurrence. The Committee agreed that substantial evidence was presented supporting the efficacy and safety of Zinplava for use in patients aged ≥18 years.
Zinplava is an investigational, fully human monoclonal IgG1/kappa antibody that binds to C. difficile toxin B. It is hypothesized that bezlotoxumab prevents binding of toxin B to colonic cells, thus averting colonic cell inflammation. It is intended to be given in conjunction with standard of care antibiotics that are used for the treatment of C. difficile infection.
Zinplava is a 1000mg strength preservative-free solution in 50mL vials for intravenous (IV) administration. It was granted Priority Review for its Biologics License Application (BLA) in January 2016.
The FDA is not bound by the Committee’s recommendation but takes its guidance into consideration for its review.
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