The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first time a freeze-dried plasma product has received a biologics license in the United States. The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.
Ezplaz is indicated for transfusion in adult patients who require plasma when other plasma products are not available — including bleeding patients, those needing massive transfusion, and certain patients on warfarin who are bleeding. It is available in Group AB and Group A with low-titer anti-B blood types, a deliberate choice to reduce risk when a patient's blood type is unknown in an emergency.
The product's key distinction from conventional plasma is its storage and handling profile. Unlike standard frozen plasma, which must be kept frozen and thawed before use, Ezplaz can be stored at room temperature, withstands temperature fluctuations, and reconstitutes rapidly. It is also packaged in a plastic bag rather than a glass bottle, reducing the risk of breakage during transport. FDA said it expects these features to make Ezplaz practical in austere environments, including combat zones, remote areas, and disaster response settings.
Each Ezplaz kit is self-contained, including one unit of freeze-dried plasma in a foil pouch, a 250 mL bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set.
"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," said Karim Mikhail, Acting Director of FDA's Center for Biologics Evaluation and Research. FDA noted the product's development was accelerated under a 2017 law authorizing a Department of Defense-FDA collaboration focused on products for serious conditions facing military personnel.
The safety profile of Ezplaz is consistent with other plasma transfusion products, the agency said.
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