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.
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Disclosure
The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.
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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.
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Markham, A. Bezlotoxumab: First Global Approval. Drugs 76, 1793–1798 (2016). https://doi.org/10.1007/s40265-016-0673-1
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DOI: https://doi.org/10.1007/s40265-016-0673-1