Emergent BioSolutions Inc. (NYSE: EBS) revealed that the Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax in Building 55, its large-scale manufacturing facility. According to the company, the regulator set a Prescription Drug User Fee Act (PDUFA) target action date of August 15.
Emergent BioSolutions' EVP and President biodefense division, Adam Havey, commented, "Emergent's large-scale 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. 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."
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The company indicated it submitted sBLA on April 15 supported by data that demonstrated that BioThrax manufactured at large scale in Building 55 was comparable to BioThrax manufactured in the currently-licensed facility. It added that BioThrax, the only FDA-licensed anthrax vaccine, was indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.
Emergent BioSolutions said this program was fully funded at $104 million.