Emergent BioSolutions announced that the 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.
Emergent recently completed a non-interference study with BioThrax. Results from this study will be used to support a supplemental Biologics License Application (sBLA) 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.
BioThrax is already approved for the prevention of disease caused by Bacillus anthracis in persons 18–65 years of age at high risk of exposure. Its use for post-exposure prophylaxis has not been approved yet.
For more information call (866) 300-7602 or visit EmergentBioSolutions.com.