The US Food and Drug Administration has licensed Ezplaz Freeze Dried Plasma. The lyophilized plasma product can be stored at room temperature and rapidly reconstituted for transfusion in adult patients. It is the first freeze-dried plasma product to be licensed for use in the US.

According to the US Food and Drug Administration (FDA), Ezplaz is a lyophilized plasma product derived from a single unit of fresh frozen plasma collected at FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, which the agency said were selected to mitigate the risk of transfusion before a patient's blood type is determined during an emergency.

Unlike conventional plasma products that require frozen storage and thawing before use, Ezplaz can be stored at room temperature, remains stable following temperature fluctuations, and is rapidly reconstituted. The product is packaged in a plastic bag rather than a glass bottle. According to the FDA, these features are expected to make Ezplaz well suited for austere environments, including combat zones, remote areas, and disaster response settings.

Karim Mikhail, BPharm, MS, Acting Director of the Center for Biologics Evaluation and Research, said, "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."

The FDA said Ezplaz is indicated when plasma is required and other plasma products are unavailable, including for bleeding patients, patients requiring massive transfusion, and certain patients receiving warfarin who are bleeding. Each kit contains one unit of freeze-dried plasma, a 250-mL bag of sterile water for injection, one sterile fluid transfer set, and one sterile blood transfusion set.

The agency noted that freeze-dried plasma was among the first products identified under Public Law 115-92, enacted in 2017, which authorized collaboration between the Department of Defense and the FDA to expedite the development and review of products for serious or life-threatening conditions affecting US military personnel. In 2019, the FDA published guidance for manufacturers developing dried plasma products for transfusion.

For the approved indication, the FDA determined that the benefits of Ezplaz outweigh the risks. The agency said the product's safety profile is consistent with that of other plasma products used for transfusion and advised health care professionals to review the full prescribing information before use. The FDA also noted that, as with all plasma products, patients and health care professionals should be aware of transfusion-associated risks. The biologics license was granted to Vascular Solutions, LLC.

Source: US Food and Drug Administration