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.
[2] BAT was first approved in 2010 by the Centers for Disease Control for the indication of treating naturally occurring non-infant botulism on an investigational basis, replacing two earlier products.
Compared to whole antibodies, as found in trivalent botulinum antitoxin (TBAT) available from local health departments (via the CDC), F(ab')2 is less efficacious at neutralizing toxin,[6] but should carry a reduced risk of anaphylaxis.
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).
[9] On June 1, 2006, the DHHS awarded a $363 million contract to Emergent BioSolutions, (then Cangene Corporation) for 200,000 doses of BAT over five years for delivery into the US Strategic National Stockpile (SNS).
[12] In March 2017, Emergent extended its contract with the Biomedical Advanced Research and Development Authority (BARDA), adding $53 million in value throughout 2022 for the production and bulk storage of BAT.
We expect to expand upon our longstanding relationship with the Canadian government and develop similar relations outside of North America..."[13] BAT was approved by the Health Sciences Authority in Singapore in July 2019.
Emergent BioSolutions, in a 2017 document published to describe prescription information for BAT, said that the effectiveness of the antitoxin is based on efficacy studies that demonstrably prove increased chances of survival.
In two clinical studies cited by the company, the safety profile of BAT was proven acceptable when one or two vials of the antitoxin were intravenously delivered to healthy subjects.