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Drugs
Published in: Drugs 7/2016

01-05-2016 | AdisInsight Report

Obiltoxaximab: First Global Approval

Author: Sarah L. Greig

Published in: Drugs | Issue 7/2016

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Abstract

Obiltoxaximab (Anthim®, ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax.
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Metadata
Title
Obiltoxaximab: First Global Approval
Author
Sarah L. Greig
Publication date
01-05-2016
Publisher
Springer International Publishing
Published in
Drugs / Issue 7/2016
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-016-0577-0

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