Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax® (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years.
“Emergent is pleased with FDA’s Orphan Drug Designation of BioThrax for post-exposure prophylaxis,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This designation will help streamline discussions around regulatory requirements at our pre-BLA meeting with FDA next month. We look forward to discussing our supplemental application for the expanded indication of post-exposure prophylaxis and the role of BioThrax in the treatment of inhalation anthrax.”