FDA accepts for review Emergent BioSolutions’ sBLA for Building 55 Biothrax production

Emergent BioSolutions, Inc.’s supplemental Biologics License Application (sBLA) seeking approval for the manufacture of BioThrax (anthrax vaccine adsorbed) at the company’s Building 55 was accepted for review by the U.S. Food and Drug Administration (FDA) this week.

“Emergent’s large-scale (Building 55) manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is a response to the U.S. government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, said. “We look forward to our continued collaboration with the U.S. government to help in its commitment to protect the nation against public health threats such as anthrax.”

Data demonstrating that BioThrax manufactured at a large scale in Building 55 is comparable to that of BioThrax manufactured in the currently-licensed facility supports the sBLA, which was submitted on April 15. A Prescription Drug User Fee Act (PDUFA) was set by the FDA with a target action date of Aug. 15.

Building 55 is located at Emergent BioSolution’s manufacturing facility in Lansing, Michigan. Manufacturing BioThrax at a larger scale will also allow Emergent BioSolutions to meet the government’s goal of stockpiling 75 million doses of a licensed anthrax vaccine.

The program is fully funded at $104 million under a contract by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

BioThrax is the only FDA-licensed anthrax vaccine and is indicated for both pre- and post-exposure prophylaxis of anthrax disease. Emergent BioSolutions has supplied the Strategic National Stockpile with BioThrax since 2001 in support of the U.S. government’s biosecurity and preparedness efforts.