FDA grants orphan drug designation to CSRA’s DynPort Vaccine Company for plague vaccine.
CSRA Inc. today announced that a plague vaccine being developed by its subsidiary, DynPort Vaccine Company LLC (DVC), was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).
DVC is developing the recombinant rF1V plague vaccine on behalf of the U.S. Department of Defense (DoD). The vaccine will be used for pre-exposure prophylaxis to combat infection with Yersinia pestis, the causative agent of plague. DVC is a contractor for the Medical Countermeasure Systems Joint Vaccine Acquisition Program (MCS-JVAP) and the sponsor of the associated Investigational New Drug Application for the plague vaccine.
“We are excited the FDA has granted Orphan Drug status for rF1V vaccine,” said Gary S. Nabors, Ph.D., President of DVC. “Orphan Drug Designation provides important incentives to support the development of products for rare diseases. 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.”
The plague vaccine is being developed as an important component of the DoD’s medical countermeasures portfolio against bioterrorism agents. Drugs and biologics developed for this vaccine must receive orphan status through the FDA’s Orphan Drug Designation program. The orphan status applies to those drugs and biologics intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S.
Currently, no licensed vaccines against plague are available for human use in the U.S. The vaccine is intended to be administered to individuals considered to be at high risk for exposure to aerosolized Y. pestis.
Plague is an acute, and often fatal, disease caused by infection with Y. pestis, a gram-negative bacterium. Historically, the disease has resulted in three pandemics over the last 1,700 years. It is estimated to have caused 200 million deaths worldwide.
Plague is currently viewed as a possible agent of bioterrorism. As such, it has been classified as a Category A priority pathogen by both the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC). The rF1V vaccine was originally developed by scientists at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID).
This work was funded by the Medical Countermeasures Systems-Joint Vaccine Acquisition Program (MCS-JVAP), Department of Defense (DoD) Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.
(Source: PR Newswire)
Filed Under: Drug Discovery