BIOTHRAX

Proper Name: Anthrax Vaccine Adsorbed

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.

Advisory Board:

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.

Indications: For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.

Key Regulatory Milestones:

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

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