In a unanimous decision announced last week, the 18-member Blood Products Advisory Committee voted to recommend the heptavalent botulinum antitoxin (HBAT), developed by a Canadian pharmaceutical company, to the federal agency for approval.
HBAT is the only botulinum antitoxin currently available for use in the U.S. It is currently an investigational product controlled by the Centers for Disease Control and Prevention. Doctors must seek approval from CDC in order to administer HBAT to patients.
The antibodies contained in HBAT target all seven known types of botulinum toxins, which attack the nervous system of infected individuals and can cause paralysis or even death.
These neurotoxins infect humans through wounds or contaminated food, and have also been identified as a potential agent of biological warfare.
The drug, developed by Cangene Corporation of Fort Garry, Winnipeg, works to prevent internalization of the toxin in the nerves.
It was used on 148 patients in the U.S. between January of 2008 and December of 2012 at part of CDC’s trial program, according to the company’s briefing document for the committee. Adminisration of HBAT within two days of symptom onset significantly reduced the duration of hospitalization for patients.
FDA will decide whether to approve HBAT for licensing, under the proprietary name BAT™, in March of this year.