FDA Advisory Committee Votes in Favour of Cangene's Botulism Antitoxin Product
WINNIPEG, Feb. 12, 2013 /CNW/ - Cangene Corporation (Cangene) today announces that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) voted unanimously in support of the questions posed by the FDA on Cangene's Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) in that there is a likely clinical benefit and an acceptable risk to benefit profile for the product, and that the studies adequately support the proposed dosing in adults. Cangene is seeking licensure for the product for the treatment of symptomatic botulism following documented or suspected exposure to the botulinum neurotoxin serotypes A, B, C, D, E, F or G.
In September 2012, Cangene submitted a Biologics License Application (BLA) for the Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) with the proposed proprietary name BAT™. The product previously received orphan drug designation in June 2011 which provides for seven years of market exclusivity following the approval of the product by the FDA. BPAC provides non-binding recommendations to the FDA which makes the final decision in respect of the approval of the product. The target date for the approval of BAT by the FDA under the Prescription Drug User Fee Act (PDUFA) is March 22, 2013.
BAT is an investigational product containing antibodies specific for the seven botulinum neurotoxin serotypes A, B, C, D, E, F or G. Botulinum neurotoxins are the bacterial toxins that cause botulism. These toxins can occur naturally in improperly processed foods and have also been identified as a potential biological warfare agent. While still an investigational product, Cangene's BAT is the only botulinum antitoxin available in the U.S. for treating naturally occurring non-infant botulism and is administered to patients under emergency conditions.
"We are pleased with the outcome of today's hearing which marks a significant milestone on the path to licensure for our BAT product" says John A. Sedor, President and CEO of Cangene. "Through many years of development, our commitment to patients has never wavered as we seek to address an unmet medical need" adds Mr. Sedor.
BAT has been developed under a $427 Million contract with the U.S. Department of Health and Human Services (HHS) and has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA). Under the terms of the contract, Cangene will receive a supplementary payment if the product is approved by the FDA. BAT was first accepted into the United States Strategic National Stockpile (SNS) in 2007.