REGULATORY UPDATE: FDA Grants Emergency Use Authorization of octaplasLG Powder for the US Military

The U.S. Food and Drug Administration (FDA) issued a new emergency use authorization last week to permit the emergency use of octaplasLG powder (blood group types A and AB) by U.S. military forces in the treatment of hemorrhage or coagulopathy involving agents of military combat when plasma is not available for use or when the use of plasma is not practical. According to FDA, the emergency use authorization permits treatment with octaplasLG powder of U.S military forces, which may include “troops, civilians, contractors and allied military personnel operating with Department of Defense” when appropriate.

Hemorrhage, and accompanying coagulopathy, is a leading cause of mortality among combat trauma casualties. Plasma transfusion is an effective treatment for hemorrhage, but its use in combat settings is often limited by logistical and operational challenges. octaPlasLG powder is a powdered freeze-dried product that can be used following reconstitution in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury.