BioThrax is the only FDA approved product for pre-exposure prophylaxis of anthrax infection. The company is targeting a three dose regimen given two weeks apart for this indication.
“We are extremely pleased that the FDA has taken this step as we continue our efforts to expand the label indication for BioThrax to include, in combination with antibiotics, its use for post-exposure prophylaxis for anthrax infection,” said Fuad El-Hibri, chairman and CEO of Emergent BioSolutions.
“Our ongoing BioThrax enhancement programs are critically important and are designed to address the US government's requirements in protecting our front-line forces as well as to building a national stockpile of safe and effective countermeasures against the use of anthrax as a weapon of bioterrorism.”
Fast track designation expedites the development and review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.