WASHINGTON, D.C. — The Food and Drug Administration licensed the first freeze-dried plasma product for U.S. use last week, creating a room-temperature option for treating adult patients when conventional plasma is unavailable in combat zones, disaster areas and other remote settings.
Ezplaz Freeze Dried Plasma is intended for adults who require plasma transfusions, including bleeding patients, those receiving massive transfusions and certain patients taking warfarin, the FDA stated.
Unlike conventional plasma, which must remain frozen and be thawed before transfusion, Ezplaz can be stored at room temperature and rapidly mixed with sterile water when needed. The product is also designed to withstand temperature fluctuations that can complicate storage and transport outside hospitals.
“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research, stated.
The authorization could expand access to plasma in locations without freezers, reliable electricity or established blood-bank infrastructure. The FDA identified military operations, emergency response and rural medicine as potential uses.
Ezplaz is produced by freeze-drying a single unit of fresh frozen plasma collected from an FDA-licensed blood establishment. It will be available as Group AB plasma and Group A plasma with low levels of anti-B antibodies, blood types selected to reduce transfusion risks when a patient’s type is unknown.
Each kit contains one unit of freeze-dried plasma, a 250-milliliter bag of sterile water, a fluid-transfer set and a blood-transfusion set. The product is packaged in a plastic bag instead of a glass bottle to reduce the possibility of breakage during transport or handling.
The FDA determined that the benefits of Ezplaz outweigh its risks for the licensed uses. Its safety profile is consistent with other plasma products, though it carries the risks associated with blood-product transfusions, the agency stated.
The product emerged from a federal effort to accelerate treatments for serious or life-threatening conditions affecting military personnel. Congress authorized a Defense Department-FDA collaboration in 2017, and the FDA issued guidance for dried-plasma developers in 2019.
“This licensure demonstrates that innovation and rigorous scientific review can advance together,” Anne Eder, director of the FDA’s Office of Blood Research and Review, stated.
The FDA granted the biologics license to Vascular Solutions LLC, a subsidiary of Teleflex.
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