A plague vaccine being developed by a CSRA subsidiary has received orphan drug status from the U.S. Food and Drug Administration as a treatment for pre-exposure prophlaxis of Yersinia pestis infection.
CSRA said Wednesday its DynPort Vaccine Company works with the Defense Department on the development of the recombinant rF1V plague vaccine that will be added to the DoD’s medical countermeasures portfolio against bioterrorism agents.
FDA grants orphan status to drugs and biologic compounds designed to diagnose, prevent or treat medical condictions that affect less than 200,000 people in the U.S.
“Orphan Drug Designation provides important incentives to support the development of products for rare diseases,” said DVC President Gary Nabors.
“These incentives include the waiving of prescription drug user fees and the ability to market the vaccine exclusively in the U.S. for seven years following approval,” Nabors added.
DoD’s Medical Countermeasures Systems-Joint Vaccine Acquisition Program funded the development of the rF1V vaccine, which was originally developed at the U.S. Army Medical Research Institute of Infectious Diseases.
The National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention classified plague as a Category A priority pathogen due to its potential to be used as an agent of bioterrorism.