FDA Approves Botulism Countermeasure

CDC began developing Botulism Antitoxin Heptavalent about 10 years ago, and it became one of the first medical countermeasures approved for advanced development and procurement under Project BioShield, in 2006.

HHS has approved Botulism Antitoxin Heptavalent, the agency's Assistant Secretary for Preparedness and Response Dr. Nicole Lurie announced March 22, saying U.S. preparedness "took another important step today with the U.S. Food and Drug Administration's approval of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine), the only product to neutralize all known botulinum nerve toxin serotypes that cause botulism. Botulinum nerve toxins are among the most potent toxins, and if patients are left untreated, the toxins may cause muscular paralysis and can lead to death. This new antitoxin is the only product available for the treatment of botulism in adults and children older than 1 year of age. It is also the only one available to treat infant botulism caused by nerve toxins other than types A and B. My office's Biomedical Advanced Research and Development Authority is proud to have been a part of the development of this drug, which addresses an urgent medical need and a national bioterrorism threat.

Her statement said about 100 people in the United States are hospitalized with botulism per year from eating improperly preserved food or by absorbing the toxin secreted by bacteria that have infected a wound or the intestine. "Importantly, botulinum nerve toxins also can be used as a bioweapon. A biological terrorism event with botulinum nerve toxins would require a rapid health response with potentially little time to determine which botulism toxin was used. This new drug can be used to treat all known botulinum nerve toxin serotypes and can be used quickly in this type of public health emergency," she explained.

CDC began developing Botulism Antitoxin Heptavalent about 10 years ago, and it became one of the first medical countermeasures approved for advanced development and procurement under Project BioShield, in 2006. "Today's approval demonstrates how well this program works in moving emergency medical countermeasures from initial research and development to approval, so the products are available in our nation's moment of need," Lurie said.

It is the first botulism product approved by the FDA and the second antitoxin to address a bioterrorism threat under Project BioShield and approved by FDA.

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