March 22, 2013
FDA approval of Botulism Antitoxin Heptavalent, statement from HHS Assistant Secretary for Preparedness and Response Dr. Nicole Lurie
“Our nation’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.
“Each year, approximately 100 people in the United States are hospitalized with botulism due to ingestion of the toxin from 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. Because this new drug is approved to treat all known botulinum nerve toxin serotypes, the antitoxin can be used readily in this type of public health emergency.
Development of Botulism Antitoxin Heptavalent began 10 years ago through the Centers for Disease Control and Prevention. In 2006, Botulism Antitoxin Heptavalent became one of the first medical countermeasures to receive support for advanced development and procurement under Project BioShield. 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.
Today, Botulism Antitoxin Heptavalent holds the distinction of being the first botulism product approved by the FDA, as well being as the second antitoxin to address a bioterrorism threat to be supported under Project BioShield and approved by FDA. BARDA, which manages Project BioShield, is procuring the drug so that it can be readily available from the Strategic National Stockpile to protect health and save lives when every moment counts.”