Emergent BioSolutions (EBS) Advances Program Supporting Licensure of a Post-Exposure Prophylaxis Indication for BioThrax
7/11/2013 10:22:45 AM
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ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) today announced that its pivotal Phase 3 clinical study evaluating the immunogenicity and safety of a three-dose BioThrax® (Anthrax Vaccine Adsorbed) regimen for post-exposure prophylaxis (PEP) has been completed and has met its primary and key secondary endpoints. The company has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA) and these results will be used to support an eventual supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. BioThrax is not licensed for use in a post-exposure setting.
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