Emergent BioSolutions has filed a supplemental Biologics License Application with the U.S. Food and Drug Administration to scale up production of its anthrax vaccine BioThrax.
BioThrax is the only FDA-approved anthrax vaccine for humans. It's primarily produced for and purchased by the U.S. military, and has been in distribution since the 1970s.
Emergent's most recent application concerning BioThrax said production of the vaccine would begin in its large-scale production facility known as "Building 55."
“Emergent is pleased to have reached this significant milestone in our BioThrax comparability program," Biodefense Division President and Executive Vice President Adam Havey said. "We believe that our submission conveys the robustness of our large-scale manufacturing process, the comparable product attributes, and the efficacy and consistency of the product from our new facility, supported by a variety of developmental and pivotal nonclinical studies. This milestone reflects many years of steadfast dedication from our project team and their effective collaboration with the U.S. government.”
Havey said the company expect the FDA to complete its review of Emergent's recent application by the fall.