The US Food and Drug Administration (FDA) on 19 April issued draft guidance that encourages sponsors to have “early and ongoing” communication with the agency in developing drugs to prevent or treat acute radiation syndrome (ARS), in an effort to overcome some of the challenges in developing these drugs.
ARS applies to a variety of clinical indications resulting from high doses of exposure to radiation. The Centers for Disease Control and Prevention (CDC) defines ARS as “an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time (usually a matter of 45 minutes).”
The guidance is not intended for drugs treating the “downstream effect” of exposure such as sepsis and does not address delayed effects of acute radiation exposure, such as radiation-induced lung injury.
Treatments for ARS are approved under FDA’s Animal Rule, which is a pathway to approve a drug or biological product without human clinical trials in limited circumstances, when human clinical trials are not ethical or feasible…
