U.S. drug regulators deem a therapy developed by Cangene likely to be effective in humans to protect against a toxin considered a bioterrorism threat.
Botulinum neurotoxin has long been judged a potential biological warfare agent, and there are currently no licensed vaccines to prevent botulism, a paralytic illness that can be fatal. Based on data from both animal and human studies, the FDA said in a report ahead of a Feb. 12 Blood Products Advisory Committee meeting that Cangene's antitoxin for botulism is safe, and the benefits of the drug outweigh the risks.
The only existing available treatment for botulism is infusion of antitoxin antibodies to remove the circulating toxin to prevent neural damage.
The company has submitted a biologics license application for its Botulism Antitoxin Heptavalent.
"A study examining the safety of BAT in healthy human subjects was performed and concluded that the biological product was well tolerated," the FDA report says.
In one of the animal studies, none of the monkeys with botulism that were treated with a placebo survived, whereas 14 of 30 treated with BAT survived to the end of the study, marking a "statistically increased survival and median time-to-death," FDA staff wrote.
Bloomberg reports that in 2006, the U.S. government awarded Cangene a contract now valued at $476 million for late-stage development of the antitoxin and 200,000 doses, according to the Department of Health and Human Services.