FDA grants Fast Track Designation for Emergent BioSolutions' NuThrax vaccine

Jun 10 2011

Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational anthrax vaccine, NuThrax^TM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also known as AV7909, consists of BioThrax^® (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory oligodeoxynucleotide compound, CPG 7909, and is currently being evaluated in a Phase 1b clinical trial for safety, tolerability, and immunogenicity. The FDA's Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.

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