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Food and Drug Administration (FDA) Corner

NIAID-Funded Research Leads to FDA Approvals of Drugs for Radiation Injury

In a Good Laboratory Practice (GLP) study, NIAID-funded researchers reported that the growth factor drug filgrastim (trade name Neupogen) 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. They also agreed that these animal-model efficacy results could likely be generalized to similar growth factor drugs. Because human studies of drug efficacy cannot be performed ethically, FDA approved filgrastim as a radiation medical countermeasure under its Animal Rule in March 2015. In November 2015, the agency approved pegfilgrastim (trade name Neulasta) for the same indication. These approvals will improve access to the drugs during a public health emergency.

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Last Updated December 03, 2015