Courtesy Photo | Soldiers with the U.S. Army 11th Airborne Division test a Freeze-Dried Plasma kit as...... read more read more
A U.S. Army Medical Materiel Development Activity commercial partner received Emergency Use Authorization from the U.S. Food and Drug Administration for the Department of Defense to use octaplasLG Powder—a potentially lifesaving treatment option for blood replacement therapies in certain operational circumstances. Notice of the EUA for this product was received by the company, Octapharma USA, on Aug. 8, 2024.
USAMMDA’s Warfighter Protection and Acute Care Project Management Office, which has a Cooperative Research and Development Agreement with Octapharma USA, manages research and development efforts for several blood products, including Freeze-Dried Plasma, for the DoD. The EUA for octaplasLG Powder is a significant milestone in WPAC’s development mission, which includes blood replacement therapies for emergent care use during military operations and training.
“The WPAC team played a vital role in assisting our commercial partner under the CRADA, helping them navigate the EUA approval request and process to give our Warfighters another tool in their aid bag in far-forward environments,” said Kendra Lawrence, Ph.D., WPAC’s program manager. “While the octaplasLG Powder is not intended to replace current FDA-approved blood replacement therapies during emergency treatment, it does give medical commands and frontline providers added capabilities when facing possible shortages of traditional blood plasma in austere locations across the world.”
The EUA authorizes U.S. military medical commands to begin procuring octaplasLG Powder (blood types A and AB) and allows military medical personnel and other authorized providers to administer the lifesaving therapy to treat hemorrhage or coagulopathy when no other FDA-approved treatments, like fresh frozen plasma, are available—or when the use of traditional plasma is not practical in a compressed time continuum during military operations.
Blood loss is a significant threat to U.S. service members during combat operations and training, and treating hemorrhage or coagulopathy is imperative to saving the lives of the wounded and injured until medevac to higher echelons of care is arranged. Logistical and supply lines during future conflicts may stretch hundreds or thousands of miles, possibly causing shortages of FDA-approved blood products at and near the point of injury. Therapies like octaplasLG Powder are designed to serve as a stopgap when whole blood, fresh frozen plasma, or liquid plasma are in short supply, according to U.S. Army Maj. Andrea Mountney, WPAC’s military deputy project manager.
“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,” said Mountney. “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.
The WPAC team provides solutions for capability gaps, working with stakeholders across the DoD, academia, and industry to develop treatments that are affordable, reliable, and expeditionary,” she added. “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.”
USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA Project Managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Forces community. The process takes promising technology from the Department of Defense, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product. USAMMDA Project Management Offices will transition to a Program Executive Office under the Defense Health Agency, Deputy Assistant Director for Acquisition and Sustainment.
No official endorsement of third parties or their products is made or inferred.
To read the FDA’s announcement, visit this link: https://www.fda.gov/media/180723/download
| Date Taken: | 08.21.2024 |
| Date Posted: | 08.21.2024 11:44 |
| Story ID: | 479120 |
| Location: | FORT DETRICK, MARYLAND, US |
| Web Views: | 108 |
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