NuThrax anthrax vaccine given fast track status by FDA

Emergent BioSolutions, Inc., recently announced that NuThrax, its investigational anthrax vaccine, was given fast track status by the U.S. Food and Drug Administration.

NuThrax was developed as a combination of its FDA approved anthrax vaccine, BioThrax, and a novel adjuvant known as CPG 7909. It is currently being tested in Phase Ib clinical safety, tolerability and immunogenicity trials, according to

The FDA’s Fast Track Development Program provides for an expedited regulatory review of new medicines that have the potential to fill gaps in medical coverage or to treat life threatening diseases.

“Emergent is pleased to receive Fast Track Designation for NuThrax,” Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, Inc., said, according to “Expedited regulatory review could mean more frequent communications with FDA, priority review of Biologics License Applications for our vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.”

NuThrax’s clinical trials are being conducted with the support of a joint development contract with the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services.

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National Institutes of Health

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