Emergent BioSolutions' Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation

Emergent BioSolutions Inc. EBS announced today that its investigational anthrax vaccine, NuThrax, has been granted Fast Track Designation by the U.S. Food and Drug Administration. The vaccine candidate, also known as AV7909, consists of BioThrax 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.