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Emergent seeks FDA's emergency use authorization for anthrax vaccine


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Emergent seeks FDA's emergency use authorization for anthrax vaccine

Emergent BioSolutions Inc. is seeking approval from the U.S. Food and Drug Administration for the emergency use of its experimental anthrax vaccine NuThrax.

Anthrax is an infectious disease caused by the bacterium Bacillus anthracis.

The Gaithersburg, Md.-based company submitted an application to the FDA for the potential emergency use of the vaccine, which is also known as AV7909.

NuThrax is being developed as a vaccine for the preventative treatment of anthrax resulting from suspected or confirmed exposure to the bacterium that causes the infection in conjunction with the recommended course of antimicrobial therapy.

Emergent's submission is expected to undergo review by FDA through the first half of 2019.

The application is a part of a contract awarded to Emergent in 2016 by the Biomedical Advanced Research and Development Authority, a division within an office of the U.S. Department of Health and Human Services, to develop and procure NuThrax.

The contract included a five-year base period of performance valued at about $200 million to develop the vaccine and to deliver to the strategic national stockpile an initial three million doses following emergency use authorization preapproval by FDA.