The U.S. Food and Drug Administration (FDA) has granted a biologics license to Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product approved for use in the United States. The freeze-dried plasma product is intended for transfusion in adult patients who require plasma when other plasma products are unavailable.
Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER), highlighted the importance of the approval, stating, “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.”
“This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure,” he added.
Developed from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments, Ezplaz is a freeze-dried (lyophilized) plasma product available in Group AB and Group A with low-titer anti-B blood types. These blood groups were selected to reduce the risk of transfusion before a patient’s blood type has been identified during emergencies.
Unlike conventional plasma products that require frozen storage followed by thawing before use, this freeze-dried plasma product can be stored at room temperature, withstand temperature fluctuations, and be rapidly reconstituted when needed. It is supplied in a plastic bag instead of a glass bottle, lowering the possibility of breakage during transportation and handling. According to the FDA, these characteristics make Ezplaz well suited for use in austere environments, including combat zones, remote locations, and disaster response operations.
The product is indicated for adult patients requiring plasma when alternative plasma products are unavailable, including bleeding patients, patients needing massive transfusion, or certain patients on warfarin who are bleeding. Each Ezplaz kit contains 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.
FDA Highlights Scientific Review and Military Collaboration Behind Approval
Commenting on the approval, Anne Eder, M.D, Ph.D., Director of the Office of Blood Research and Review (CBER), said, “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.”
The approval follows efforts initiated under Public Law 115-92, enacted in December 2017, which authorized the DoD (now DoW)-FDA collaboration to help accelerate the development and review of products intended for serious or life-threatening conditions affecting American military personnel. As part of that initiative, the FDA issued guidance in 2019 to support manufacturers developing dried plasma products for transfusion.
After reviewing the available data, the agency concluded that, for the approved uses, the benefits of the freeze-dried plasma product outweigh its risks. The FDA noted that the safety profile of Ezplaz is consistent with other plasma products used for transfusion, while emphasizing that patients and healthcare providers should remain aware of transfusion-related risks and that healthcare providers should review the complete prescribing information before administration. The biologics license for Ezplaz was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.
