FDA approves BioThrax administration schedule change
The FDA granted approval to a supplemental Biologics License Application filed by Emergent BioSolutions, Inc., to allow a three dose primary series of intramuscular injections at zero, one and six months.
The BioThrax booster series consists of intramuscular injections after 12 and 18 months after the primary doses and at intervals of one year for those who remain at risk. Individuals are considered protected only after completing the three dose primary series of intramuscular injections.
"Emergent applauds the Centers for Disease Control and Prevention for their dedicated research to optimize the dosing schedule of BioThrax and the FDA for a timely review and approval process," Daniel J. Abdun-Nabi, the president and chief executive officer of Emergent BioSolutions, Inc., said.
"Achieving this milestone is a testament to our continued efforts to advance BioThrax," Abdun-Nabi said. "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."
Emergent BioSolutions, Inc., filed the sBLA in 2010 after the completion of a U.S. Centers for Disease Control and Prevention study on the issue was completed in 2009.