Radiation Countermeasure Focused Product Development

Some currently-available drugs as well as approaches undergoing testing in pre-clinical models of radiation injury have shown great promise as mitigators/treatments, improving survival and enhancing other indicators such as levels of immune and other blood cells.

In fact, in 2015, label-extensions were granted by the United States Food and Drug Administration (FDA) for the use of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) to treat casualties in the wake of a radiological or nuclear incident. These approvals have paved the way for use of these already-stockpiled drugs, without the need for an Emergency Use Authorization (EUA), and has elevated their use to an expected standard of care in a mass casualty, radiation public health emergency. This approval by the FDA was based on large animal efficacy protocols supported by NIAID funding. In those GLP studies, both growth factor-based drugs improved survival when administered 24 hours after radiation exposure. 

The NIAID’s focus on product development makes the kinds of studies that resulted in these licensures available to companies and/or academic investigators who are developing drugs for a radiation indication. Activities have included independent confirmation of product efficacy in well-validated, small and large animal models of hematopoietic, gastrointestinal and lung syndromes resulting from radiation exposure; toxicological, pharmacological, and drug candidate synthesis/stability studies to gather data that can assist investigators in their applications for additional sources of funding; pivotal animal-model studies of efficacy; studies conducted under Good Laboratory Practices standards in small and large animal models as required by the FDA Animal Rule for product licensure; and additional studies to enable investigators to advance products toward FDA licensure.

Content last reviewed on January 6, 2017