Anthrax Vaccine Designated Orphan Drug for Post-Exposure Prophylaxis

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.

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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.

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