Emergent BioSolutions Inc. today announced that Health Canada has approved the company’s New Drug Submission (NDS) for its anthrax vaccine, BioThrax® (Anthrax Vaccine Adsorbed).
BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure. BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter.
BioThrax was approved under the Extraordinary Use New Drug Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.
“With the growing awareness of biological and chemical threats around the globe, Emergent is committed to partnering with allied governments and providing preparedness solutions to meet their national security needs,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head, at Emergent BioSolutions. “We are pleased to receive Health Canada licensure of BioThrax, fulfilling our commitment to the Canadian government, and enabling future procurement of this critical medical countermeasure. We look forward to continuing our decades-long partnership in our quest to fulfill our mission – to protect and enhance life.”
BioThrax is designated by Health Canada as an innovative drug giving it market exclusivity for eight years. Earlier this year, Emergent completed the Mutual Recognition Procedure for BioThrax expanding licensure of BioThrax in five European countries, namely, the U.K., Poland, France (marketed as BaciThrax), Italy, and the Netherlands, in addition to Germany, where BioThrax received market authorization in 2013.