title: Bezlotoxumab: First Global Approval.
abstract: Bezlotoxumab (Zinplava™) is a human monoclonal antibody against Clostridium difficile toxin B developed by Merck & Co. In October 2016 it was approved in the USA for reducing the recurrence of C. difficile infection. This article summarizes the milestones in the development of bezlotoxumab leading to this first approval for use in patients receiving antibacterial drug treatment for C. difficile infection who are at high risk for recurrence of C. difficile infection.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
authors.forename: Anthony
authors.initials: A
authors.lastname: Markham
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000494:pharmacology* / Q000627:therapeutic use*; D057134:Antibodies, Neutralizing / Q000494:pharmacology* / Q000627:therapeutic use*; D001426:Bacterial Proteins / Q000378:metabolism; D001427:Bacterial Toxins / Q000378:metabolism; D000080908:Broadly Neutralizing Antibodies; D016360:Clostridioides difficile / Q000187:drug effects*; D017277:Drug Approval / Q000379:methods; D004761:Enterocolitis, Pseudomembranous / Q000188:drug therapy*; D006801:Humans
chemical_list: D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D057134:Antibodies, Neutralizing; D001426:Bacterial Proteins; D001427:Bacterial Toxins; D000080908:Broadly Neutralizing Antibodies; C031815:toxB protein, Clostridium difficile; C000613978:bezlotoxumab