The US Food and Drug Administration (FDA) has licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product approved for use in the United States.
Developed by Vascular Solutions, a subsidiary of Teleflex, Ezplaz is indicated for transfusion in adults when plasma is required and other plasma products are not available, including patients with uncontrolled bleeding (hemorrhage), those requiring massive transfusions, and certain patients receiving warfarin who are bleeding.
The approval also marks Teleflex’s first biologics license for a blood component.
Unlike conventional plasma products that must be frozen and thawed before use, Ezplaz can be stored at room temperature, withstand temperature fluctuations and be reconstituted within approximately one to two-and-a-half minutes.
“EZPLAZ FDP can potentially enable the transfusion of plasma in situations where it is critically needed, including air and road ambulances, in the hospital, and on the battlefield,” said Jake Newman, President and General Manager, Global Vascular and Emergency Medicine at Teleflex.
Karim Mikhail, Acting Director of the FDA’s Center for Biologics Evaluation and Research (CBER), said the approval could significantly improve access to plasma for patients experiencing life-threatening bleeding in combat zones, disaster areas, rural settings or other austere environments where 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.
Ezplaz is produced 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, helping reduce the risk of incompatibility when a patient’s blood type is unknown during emergencies.
The product is packaged in a plastic bag instead of a glass bottle, reducing the risk of breakage during handling and transport. Each kit contains one unit of freeze-dried plasma sealed in an outer foil pouch, a 250 mL bag of sterile water for injection, a sterile fluid transfer set and a sterile blood transfusion set. It can be stored at 2°C to 25°C, has a 12-month shelf life.
According to the FDA, these features make Ezplaz suitable for use in austere environments, potentially including combat zones, remote areas and disaster response settings.
Teleflex led the product development and established manufacturing operations required to support its Investigational New Drug (IND) application and eventual licensure.
“Our clinical development program was designed to generate the evidence needed to support the safety and effectiveness of EZPLAZ FDP for its approved indication. We are grateful to the investigators, blood donors, study participants, and our government partner whose collaboration made this achievement possible,” said Christopher Ross, MD, global medical safety director and interim head of clinical and medical affairs at Teleflex.
The FDA said the benefits of Ezplaz outweigh its risks for its approved uses, noting that its safety profile is consistent with other plasma products used for transfusion.
