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Plague vaccine receives orphan drug designation from FDA
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CSRA Inc. has announced that the FDA recently granted orphan drug designation to an investigational plague vaccine that is being developed by the company’s subsidiary, DynPort Vaccine Company LLC, according to a press release.
The recombinant rF1V vaccine is being developed as a component of the Department of Defense’s medical countermeasures portfolio against bioterrorism agents, the release said. It was originally created by researchers at the United States Army Medical Research Institute of Infectious Diseases, and will be used to combat infections caused by Yersinia pestis in patients who were likely exposed to the bacteria.
“We are excited that the FDA has granted Orphan Drug status for the rF1V vaccine,” Gary S. Nabors, PhD, president of DyPort Vaccine Company, said in the release. “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 7 years following approval.”
According to the release, there have been three pandemics involving Y. pestis over the last 1,700 years. An estimated 200 million deaths worldwide have been caused by the bacterium, which has been classified as a Category A priority pathogen by the National Institute of Allergy and Infectious Diseases and the CDC.
Disclosure: Nabors is an employee of DyPort Vaccine Company.