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Food and Drug Administration (FDA) Corner

NIAID-Funded Research Could Lead to FDA Approval of Drug for Radiation Injury

In a Good Laboratory Practice (GLP) study, NIAID-funded researchers reported that the growth factor drug filgrastim nearly doubles survival in radiation-exposed monkeys. Seventy-nine percent of treated animals survived for more than 60 days after radiation exposure, compared to 41 percent of animals that did not receive the drug. Monkeys receiving filgrastim also experienced fewer infections. Based on these study results, an FDA advisory panel concluded, by a 17-1 vote, that filgrastim therapy is likely to benefit humans exposed to radiation. Because human studies of drug efficacy cannot be performed ethically, the FDA could approve filgrastim as a radiation medical countermeasure under its Animal Rule, which would improve access to this therapy during a public health emergency.

Read more: FDA Advisory Committee Meeting: May 3, 2013.  

 
 
 
 
 

Last Updated June 20, 2014

Last Reviewed June 20, 2014