Emergent Advances Program Supporting Licensure Of PEP Indication For BioThrax

(RTTNews) - Emergent BioSolutions Inc. (EBS) said Wednesday that its pivotal Phase 3 clinical study evaluating the immunogenicity and safety of a three-dose BioThrax regimen for post-exposure prophylaxis has been completed and has met its primary and key secondary endpoints.

The company said it has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority and the U.S. Food and Drug Administration and that those results will be used to support an eventual supplemental Biologics License Application seeking licensure of a post-exposure prophylaxis 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.