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.”
The sBLA was based on a Final Study Report from a large multi-center study initiated by the CDC in 2002. This study was designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses to follow, would confer an adequate immune response. CDC completed the study in 2009, and Emergent submitted the sBLA in 2010.
About Emergent BioSolutions Inc.Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com. About BioThrax BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. The safety and efficacy of BioThrax in a post-exposure setting have not been established. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.