Emergent BioSolutions Obtains Orphan Drug Designation For BioThrax - Quick Facts

(RTTNews) - Emergent BioSolutions Inc. (EBS) said Monday that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis or 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 or BLA supplemental regulatory filing fee and marketing exclusivity of up to seven years.

BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication.

Emergent recently announced completion of a non-interference study, results from which will be used to support a supplemental BLA seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores.