FDA Licenses First Freeze-Dried Plasma Product in US

• The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), a first-of-its-kind product in the US.
• Ezplaz can be stored at room temperature, making it suitable for use in austere environments such as combat zones and disaster response settings.
• The licensure of Ezplaz addresses an important unmet medical need, particularly for military personnel who may be far from traditional hospital infrastructure.

This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.

The U.S. Food and Drug Administration has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first time a freeze-dried plasma product has been approved for use in the United States. This milestone is significant because it addresses an important unmet medical need, particularly for military personnel and others who may be far from traditional hospital infrastructure. The FDA's licensure of Ezplaz comes after years of collaboration between the agency and the Department of Defense (DoD) to expedite the development and review of products for serious or life-threatening conditions facing American military personnel.

Ezplaz is a freeze-dried plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It can be stored at room temperature, making it compatible with austere environments such as combat zones, remote areas, and disaster response settings.

The licensure of Ezplaz is the result of a collaboration between the FDA and the DoD to expedite the development and review of products for serious or life-threatening conditions facing American military personnel. This effort was authorized by Public Law 115-92, enacted in December 2017, which allowed for the DoD-FDA collaboration. The FDA issued guidance in 2019 to assist manufacturers developing dried plasma products for transfusion. The licensure of Ezplaz 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 FDA granted the biologics license to Vascular Solutions, Inc., a subsidiary of Teleflex. This licensure marks an important step in addressing unmet medical needs, particularly for military personnel who may be far from traditional hospital infrastructure.

The licensure of Ezplaz has significant implications for emergency medical situations. 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 and expands treatment options for patients who require plasma transfusions. The use of Ezplaz can be particularly beneficial in situations where traditional hospital infrastructure is not available.

Lawyers advising clients on emergency medical situations may need to consider the availability and use of Ezplaz freeze-dried plasma, which can be stored at room temperature and is compatible with austere environments.

Source: Original reporting via FDA