The room-temperature-stable product provides a new option for patients in remote or austere environments where conventional frozen plasma is unavailable.
RT’s Three Key Takeaways:
- First-of-its-Kind Approval: The FDA has licensed Ezplaz, the first freeze-dried plasma product for use in the US, to treat adult patients when conventional plasma is unavailable.
- Enhanced Portability: The product is stable at room temperature, allows for rapid reconstitution, and is packaged in plastic bags to prevent breakage during transport in austere environments.
- Critical Care Application: This licensure addresses an unmet medical need for military personnel and patients in rural or disaster settings who require immediate transfusion for life-threatening bleeding, massive blood loss, or warfarin-related complications.
The USFDA has licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product approved for use in the US.
Ezplaz is intended for transfusion in adult patients who require plasma and for whom other plasma products are not available, according to the FDA. This includes patients experiencing life-threatening bleeding, those requiring massive transfusions, or certain patients on warfarin who are bleeding.
“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 the center for biologics evaluation and research (CBER). Mikhail added that the action addresses an unmet medical need for military personnel and others who are far from traditional hospital infrastructure.
Derived from single units of fresh frozen plasma, Ezplaz is available in Group AB and Group A with low-titer anti-B blood types. These types were chosen to mitigate the risk of administration during emergencies before a patient’s blood type is determined, according to the news release.
Unlike standard plasma products that must be stored frozen and thawed before use, Ezplaz is room-temperature stable and resists temperature fluctuations. The product is rapidly reconstituted and packaged in a plastic bag rather than glass to reduce the risk of breakage during handling and transport. The FDA expects these features to make the product compatible with austere environments, including combat zones, remote areas, and disaster response settings, according to the news release.
Each Ezplaz kit is a self-contained package containing one unit of freeze-dried plasma, a bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set, the news release stated.
“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, director of the office of blood research and review.
The development of the product was expedited under a 2017 law authorizing collaboration between the Department of Defense (DoD) and the FDA to assist in the review of products for life-threatening conditions facing American military personnel. In 2019, the FDA issued guidance to assist manufacturers in developing dried plasma products for transfusion.
The FDA found that the benefits of Ezplaz transfusion outweigh the risks, noting its safety profile is consistent with other plasma products used for transfusion, according to the FDA. Healthcare providers should review the full prescribing information before use, and patients and providers should remain aware of risks associated with any transfusion.
The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.
