Cangene botulism antidote receives positive acknowledgment from FDA
The U.S. Food and Drug Administration said that the antidote against the bioterrorism threat is safe and that its benefits outweigh any risk from side effects. The FDA's agency advisors are scheduled to discuss the product in mid-February, according to Bloomberg.
The Winnipeg-based Cangene currently has a contract to supply the antitoxin to the U.S. government under the emergency rule. Cangene is now seeking FDA approval based on safety studies conducted in humans and efficacy studies on guinea pigs and nonhuman primates. The FDA said in a report that a human dose of the vaccine in monkeys significantly increased survival rates and median time-to-death. The regulatory agency said it could make a decision on Cangene's application as soon as mid-March.
The U.S. government first awarded Cangene a contract for the antitoxin in 2006. The contract is now valued at $476 million for late-stage development and a delivery of 200,000 doses to be placed in the U.S. Strategic National Stockpile, Bloomberg reports.
The botulinum toxin is considered a major potential weapon of bioterrorism, especially if dispersed in aerosolized form. Botulism, the name of the resulting infection, causes paralysis that can lead to death because the muscles responsible for breathing stop functioning.