The US Food and Drug Administration (FDA) has authorized octaplasLG Powder blood transfusion capability for tactical emergency use to treat excessive bleeding.
This approval allows US Department of Defense medical providers and related military specialists to administer the solution to servicemen, civilians, contractors, and allied forces during military operations “at the point-of-injury in far-forward and austere environments.”
The powder’s application is not meant to replace existing methods such as traditional fresh-frozen plasma but will serve as an alternative when treatments are unavailable and the conditions are in scope within the FDA’s Emergency Use Authorization guidelines.
The octaplasLG Powder
Developed by New Jersey-based biotechnology firm Octapharma USA, the octaplasLG Powder is a lyophilized or freeze-dried form of the company’s FDA-approved Octaplas pooled plasma solvent/detergent treated solution for intravenous infusion.
The pack is limited to blood types A and AB, which can be transfused to patients of any blood group in an event where required classifications cannot be validated during emergencies.
Blood content for the octaplasLG was obtained via US-based licensed blood centers, all of which were tested for transfusion-transmitted infections according to federal regulations.
Currently, Octapharma’s powder is available in 27 countries for emergency use.
“Octapharma is committed to providing the US military with a safe alternative to fresh frozen plasma when life-threatening hemorrhage or coagulopathy needs to be addressed during emergencies,” Octapharma USA Flemming Nielsen President explained.
“For many years, Octapharma has recognized the challenges of managing excessive bleeding and blood clotting challenges in emergency situations.”
“Over the last two decades, Octapharma has funded extensive research and development of octaplasLG Powder to demonstrate our vision to provide patients worldwide the critical care therapies they need to overcome life-threatening challenges.”
Support for Future Operations
Octapharma noted in the announcement that it has already entered into a Cooperative Research and Development Agreement (CRADA) with the US Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care (WPAC) Project Management Office for collaborative studies on the octaplasLG Powder.
Tasks will involve laboratory tests to identify the technology’s appropriate and safe usage while building cases for side effects and medication data.
Additionally, the consortium will gather information on the powder’s efficacy when coupled with its predecessor Octaplas.
“During combat operations, whether in the Arctic, the Indo-Pacific, or other regions of interest, we will be facing the dual challenges of time and distance due to the austerity of those operating environments,” US Army WPAC Deputy Project Manager Maj. Andrea Mountney stated.
“Each passing second after a Service member is wounded or injured increases the complications caused by combat trauma. The longer it takes to begin blood replacement therapy, the higher the chances of mortality.”
“Our goal is to meet the needs of the customer—the Joint Service end-user who may one day need these life-saving treatments. Solutions like octaplasLG Powder go a long way to equip our medical providers with the tools needed to treat the Warfighter during future operations.”
