BETHESDA, MD 25 March 2013—Cangene Corporation of Winnipeg, Canada, this morning announced the approval of Botulism Antitoxin Heptavalent for the treatment of naturally occurring botulism and for use as a biodefense agent.
The horse-serum-derived antitoxin neutralizes all seven known serotypes of botulinum nerve toxin—types A, B, C, D, E, F, and G—and was developed through a contract with the Biomedical Advanced Research and Development Authority (BARDA). By 2018, a total of 200,000 doses of the product will be delivered to the Strategic National Stockpile, according to the company.
for the product is available online.
Although it was developed as a biodefense product, the antitoxin has been used since 2009 as an investigational treatment for naturally occurring, noninfant botulism in the United States, Cangene stated.
Botulinum toxin is produced by Clostridium botulinum bacteria. When inhaled, ingested, or introduced into a wound, the toxin causes serious paralysis that may lead to the inability to breathe. According to FDA, Cangene's product is the only one available in the United States for the treatment of botulism in adults and in infants whose illness is caused by neurotoxins other than types A or B.
The safety of the antitoxin was tested in 40 healthy human subjects and 228 patients who received the drug under emergency conditions as an investigational treatment for botulism. Efficacy studies were performed in animals only.
According to FDA, the most commonly reported adverse events in people who received the antitoxin were headache, fever, chills, rash, itching, and nausea. The agency noted that a delayed hypersensitivity reaction may occur in patients who are sensitive to horse proteins.
Distribution of the product for patients with naturally occurring botulism is coordinated through the Centers for Disease Control and Prevention's drug service.