BioCentury
ARTICLE | Company News

FDA to discuss Cangene's botulism antitoxin

January 15, 2013 1:59 AM UTC

FDA's Blood Products Advisory Committee will meet on Feb. 12 to discuss a BLA from Cangene Corp. (TSX:CNJ) for botulism antitoxin heptavalent (BAT) to treat botulism. The company is seeking approval for the heptavalent hyperimmune preparation containing neutralizing antibodies to the seven different botulinum toxin types 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. Cangene submitted the BLA in September 2012; the PDUFA date is not disclosed. ...