Room-temperature-stable and rapidly reconstituted, this first FDA-licensed product brings new options to emergency and remote settings
The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
“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, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
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 that these features will make the use of Ezplaz compatible with austere environments, potentially including combat zones, remote areas, and disaster response settings.
Ezplaz is indicated for transfusion in adults when plasma is required and other plasma products are not available, including bleeding patients, patients needing massive transfusion or certain patients on warfarin who are bleeding.
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.
“This licensure demonstrates that innovation and rigorous scientific review can advance together, expanding treatment options and novel blood components while maintaining FDA’s standards for safety, purity, and potency,” said Anne Eder, M.D, Ph.D., Director of the Office of Blood Research and Review (CBER).
Freeze-dried plasma was among the first products identified under Public Law 115-92, enacted in December 2017, which authorized the DoD (now DoW)-FDA collaboration for assistance to expedite the development and review of products for serious or life-threatening conditions facing American military personnel. Accordingly, the FDA issued guidance in 2019 to assist manufacturers developing dried plasma products for transfusion.
For uses of Ezplaz that are approved under the license, FDA has found that the benefits of Ezplaz transfusion outweigh the risks. The safety profile of Ezplaz is consistent with other plasma products used for transfusion. As with all plasma products, patients and healthcare providers should be aware of risks associated with transfusion. Healthcare providers should review the full prescribing information before use.
The FDA granted the biologics license to Vascular Solutions, LLC, a subsidiary of
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