Bezlotoxumab, sold under the brand name Zinplava, is a human monoclonal antibody designed for the prevention of recurrence of Clostridioides difficile infections.
[3] By x-ray crystallized structure of N-terminal of Clostridioides difficile toxin B (TcdB), the toxin was identified to consist of three domains: a GTD, a cysteine protease and a combined repetitive oligopeptides, CROP domain.
[5] This drug, along with actoxumab, was developed through phase II efficacy trials by a partnership between Medarex Inc and MassBiologics of the University of Massachusetts Medical School.
[8] In June 2016, the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration[9] voted to recommend approval of Merck's license application for bezlotoxumab by a vote of 10 to 5, generally expressing a willingness to accept that the trials had proven that bezlotoxumab decreased recurrence of C. difficile overall.
Although the patient population as a whole contained many very sick individuals and thus there were many adverse events in both the subjects receiving a placebo and those receiving bezlotoxumab, the panel focused on a small number of serious events in patients with pre-existing congestive heart failure.