FDA Approves First Freeze-Dried Plasma Product

The U.S. Food and Drug Administration (FDA) has licensed Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product licensed for use in the U.S. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.

Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.

Unlike conventional plasma products that must be stored frozen and thawed before use, Ezplaz can be stored at room temperature, is stable after exposure to temperature fluctuations and is rapidly reconstituted. It is packaged in a plastic bag rather than a glass bottle, reducing the risk of breakage during handling and transport. FDA expects these features will make the use of Ezplaz compatible with austere environments, potentially including combat zones, remote areas and disaster response settings.

Each Ezplaz kit is a complete, self-contained package containing one unit of freeze-dried plasma sealed in an outer foil pouch, one 250 mL bag of sterile water for injection, one sterile fluid transfer set and one 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, BPharm, MS, acting director of the Center for Biologics Evaluation and Research. “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”