It is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, non-encapsulated strain of Bacillus anthracis.
1970s - BioThrax originally approved
12/11/2008 - approved a change to an intramuscularly (IM) administered five-dose primary series (Week 0 and 4; and Month 6, 12, and 18) followed by an annual booster thereafter.
05/17/2012 - change in dosing schedule for BioThrax was approved
04/11/2014 - received orphan drug-designation for the indication of “post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.”
11/23/2015 - FDA approval date
11/29/2015 - PDUFA Goal Date
The question of which immune response and what study design should be used to determine protective antibody levels in the animals that could be extrapolated to humans for a postexposure prophylaxis indication was discussed at the VRBPAC held on November 16, 2010. At that meeting, a scientific strategy for bridging animal protection data to humans for PA-based vaccines, including BioThrax, was agreed upon.