FDA GRANTS FAST-TRACK STATUS TO NEW BIOTHRAX INDICATION
Emergent BioSolutions announced that the FDA has granted fast-track designation to its BioThrax anthrax vaccine as a post-exposure prophylaxis against anthrax infection. BioThrax is the only FDA-approved product for pre-exposure prophylaxis of anthrax infection.
The company plans to seek FDA approval of BioThrax for use in combination with antibiotics as a post-exposure prophylaxis for anthrax infection and is conducting clinical and non-clinical trials to support a three-dose regimen given two weeks apart.
"Our ongoing BioThrax enhancement programs are critically important and are designed to address the U.S. government's requirements in protecting our front-line forces as well as to build a national stockpile of safe and effective countermeasures against the use of anthrax as a weapon of bioterrorism," Fuad El-Hibri, chairman and CEO of Emergent BioSolutions, said.
Under the FDA Modernization Act of 1997, 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, according to Emergent.