Orphan drug status 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 BioSolutions executive vice president and president of biodefense division Adam Havey said the company is happy with FDA’s Orphan Drug Designation of BioThrax for post-exposure prophylaxis.
"This designation will help streamline discussions around regulatory requirements at our pre-BLA meeting with FDA next month," Havey said.
"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."
BioThrax, which is the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication.
The company recently completed a non-interference trial and its results will be used to support a supplemental BLA seeking licensure of a PEP indication for the drug to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores.