FDA panel backs Cangene's botulism antitoxin

FDA's Blood Products Advisory Committee unanimously recommended approval on Tuesday of botulism antitoxin heptavalent (BAT) from Cangene Corp. (TSX:CNJ) to treat botulism. The committee said there is sufficient evidence from animal efficacy studies that BAT is "reasonably likely" to provide clinical benefit and that safety data from healthy volunteers support an acceptable risk/benefit profile. Cangene is seeking approval for BAT under FDA's animal rule, which allows for marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. The product is a heptavalent hyperimmune preparation containing neutralizing antibodies to the seven different botulinum toxin types. ...