Health Canada recently approved a new drug submission from Emergent BioSolutions, Inc. for its botulism antitoxin, BAT, which is indicated for the treatment of symptomatic botulism. BAT is administered following documented or suspected exposure to botulinum neurotoxin serotypes A through G in adults and pediatric patients.
Botulism, a type of food poisoning, occurs when bacterium or botulinum contaminates canned food or packaged water. The treatment was approved under the extraordinary use new drug regulations, which provide regulatory pathway for products where collecting clinical information for its intended purpose is logistically or ethically not feasible.
“Emergent is pleased that Health Canada has approved this critical countermeasure against botulinum toxin, which has been identified by the U.S. Centers for Disease Control and Prevention and Public Health Agency of Canada as one of the more likely biological threat agents,” Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, said.
The company had an existing contract, which was originally signed in 2012, to supply BAT to the Canadian Department of National Defense and the Public Health Agency of Canada. As part of a $450 million contract with the U.S. Biomedical Advanced Research and Development Authority, Emergent has been supplying BAT to the U.S. Strategic National Stockpile as well. Since being licensed by the U.S. Food and Drug Administration in 2013, BAT is the only botulism antitoxin available in the U.S. for treating naturally-occurring, non-infant botulism. It is also approved for administration to patients under emergency conditions.
“Emergent is committed to helping allied governments fulfill their preparedness needs,” Havey said. “We expect to expand upon our longstanding relationship with the Canadian government and develop similar relations outside of North America as a key strategic objective for the organization.”