FDA approves Cangene's botulism toxin antidote
The Winnipeg, Canada-based Cangene supplies its botulism antitoxin to the United States under an emergency-use exemption. Cangene was awarded a contract in 2006, which is now valued at $476 million, for late-stage development of the antitoxin and 200,000 doses, Bloomberg reports.
"This product approval meets an urgent unmet medical need for the treatment of sporadic cases of life-threatening botulism and provides a medical countermeasure should botulinum nerve toxins be used in a terrorism event," Karen Midthun, the director of the FDA's Center for Biologics Evaluation and Research, said, according to Bloomberg.
Cangene found in a study of monkeys that 14 of 30 monkeys given the antitoxin survived when exposed to botulism toxin while none of the 30 in the placebo group survived.
"These results provided substantial evidence that the antitoxin is reasonably likely to benefit humans with botulism," the FDA said, according to Bloomberg. "Under the FDA's Animal Rule, the agency may approve a biological product when the results of well-controlled animal studies demonstrate that the product is reasonably likely to be effective, in addition to establishing safety in humans. This is the first approval of a plasma derivative using the Animal Rule."
Botulism can result in paralysis of the body's airways and breathing muscles that result in death. The toxin can be used as a weapon of bioterrorism if released deliberately in either an aerosolized form or in food and drink.
The botulism toxin can also occur naturally in food and drink, especially in food that is canned incorrectly, or in contaminated wounds, the Center for Biosecurity of the University of Pittsburgh Medical Center in Baltimore, Maryland reports. Approximately 110 botulism cases are reported annually, Bloomberg reports.