FDA approves Emergent’s BioThrax sBLA to treat anthrax disease

Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax^® (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months. The booster series consists of intramuscular injections at 12 and 18 months after initiation of the primary series, and at 1-year intervals thereafter for those who remain at risk. Individuals are not considered protected until they have completed the three-dose primary immunization series. BioThrax is the only FDA-licensed vaccine for pre-exposure protection of adults against anthrax disease.    

"Emergent applauds the Centers for Disease Control and Prevention (CDC) for their dedicated research to optimize the dosing schedule of BioThrax and the FDA for a timely review and approval process. Achieving this milestone is a testament to our continued efforts to advance BioThrax," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "We are pleased that the U.S. government shares our commitment to enhance the utility of BioThrax and its attractiveness as protection for military personnel deployed in high risk areas."