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The ''Heptavalent Botulism AntiToxin'' — ''HBAT'', made by Cangene Corporation — is a licensed, commercially available botulism anti-toxin that effectively neutralizes all seven known botulinum nerve toxin serotypes (types A, B, C, D, E, F and G). It is indicated for sporadic cases of life-threatening botulism and is also stockpiled for the eventuality of botulinum nerve toxins being used in a future bioterrorist attack. ''HBAT'' was approved in 2010 by the CDC for the indication of treating naturally occurring non-infant botulism on an investigational basis, replacing two earlier products. It was licensed for commercial marketing by the FDA in 2013. ==History== ''HBAT'' was developed from equine (horse) plasma at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The main funding stream was the Biomedical Advanced Research and Development Authority (within the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response). It was then available for many years on an IND (investigational) basis from the US Centers for Disease Control and Prevention (CDC). On June 1, 2006, the DHHS awarded a $363 million contract to Cangene Corporation for 200,000 doses of ''HBAT'' over five years for delivery into the US Strategic National Stockpile (SNS). The CDC began supplying doses to the SNS in 2007 under a now $427 million contract with the DHHS, according to a Cangene press release. In 2010, the CDC replaced the licensed bivalent botulinum antitoxin AB (''BAT-AB'', or “BabyBIG”) and the investigational monovalent botulinum antitoxin E (''BAT-E'') with ''HBAT'' when the former two products indications expired. This action left ''HBAT'' as the only botulinum antitoxin available in the US for naturally occurring non-infant botulism. On 22 March 2013, the US Food and Drug Administration (FDA) approved ''HBAT'' as the first product to treat all serotypes of botulism. This was considered a significant step in the US armamentarium for emergency use against a bioterrorist attack. The CDC continues to distribute the stockpiled antitoxin. The FDA approved ''HBAT'' for marketing based on its efficacy as established in animal studies (efficacy trials in humans not being considered feasible or ethical). The safety of the antitoxin, however, was established in a study of 40 healthy volunteers as well as in the experimental treatment of 228 patients in a CDC program. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Heptavalent botulism antitoxin」の詳細全文を読む スポンサード リンク
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