Bezlotoxumab: First Global Approval

Drugs. 2016 Dec;76(18):1793-1798. doi: 10.1007/s40265-016-0673-1.

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.

Publication types

  • Review

MeSH terms

  • Animals
  • Anti-Bacterial Agents / pharmacology
  • Anti-Bacterial Agents / therapeutic use
  • Antibodies, Monoclonal / pharmacology*
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Neutralizing / pharmacology*
  • Antibodies, Neutralizing / therapeutic use*
  • Bacterial Proteins / metabolism
  • Bacterial Toxins / metabolism
  • Broadly Neutralizing Antibodies
  • Clostridioides difficile / drug effects*
  • Drug Approval / methods
  • Enterocolitis, Pseudomembranous / drug therapy*
  • Humans

Substances

  • Anti-Bacterial Agents
  • Antibodies, Monoclonal
  • Antibodies, Neutralizing
  • Bacterial Proteins
  • Bacterial Toxins
  • Broadly Neutralizing Antibodies
  • toxB protein, Clostridium difficile
  • bezlotoxumab