Cutaneous Radiation Injuries: Models, Assessment and Treatments

Abstract

In the wake of the terrorist attacks on September 11, 2001, the U.S. Government re-focused attention on the potential threat from a radiological or nuclear incident on U.S. soil. In response to growing concerns about the ability of the Government to mount a medical response to such a disaster, several agencies were tasked with the mission to support research to develop medical countermeasures (MCMs) to diagnose (biodosimetry) and treat radiation injuries in the wake of a mass casualty, public health emergency. One of these organizations was the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), within the Department of Health and Human Services (HHS). Since 2004, the NIAID has supported countermeasure development across the entire spectrum of radiation research: development of animal models, basic research to identify and target biological pathways involved in the radiation damage response, and advanced development of approaches needed to obtain approval² for marketing by the U.S. Food and Drug Administration (FDA). The Biomedical Advanced Research and Development Authority (BARDA), also a part of HHS, supports late-stage activities needed for product approval and is responsible for procurement of products to be placed in the U.S. Strategic National Stockpile (SNS). In parallel, the FDA provides guidance to drug developers seeking approval of products for a radiation countermeasures indication, for which efficacy studies in humans cannot be feasibly or ethically obtained. Referred to as the “Animal Rule” (1), the FDA created a pathway that has been used to obtain approval for three MCMs to treat hematopoietic complications resulting from radiation exposure: filgrastim (Neupogen^®, FDA approved March 2015);³ pegfilgrastim (Neulasta^®, FDA approved November 2015);⁴ and sargramostim (Leukine^®, FDA approved March 2018).⁵