The U.S. Food and Drug Administration has licensed the first freeze-dried plasma product for use in the United States, clearing a room-temperature-stable blood product it says could speed transfusions in combat zones, disaster sites, and other remote settings.
The product, Ezplaz Freeze Dried Plasma, is manufactured by Vascular Solutions, LLC, a subsidiary of Teleflex. It is licensed for adult patients who need plasma and for whom other plasma products are not available — including people with active bleeding, patients requiring massive transfusion, and certain warfarin patients who are bleeding, the agency said.
Unlike conventional plasma, which must be kept frozen and thawed before use, Ezplaz is lyophilized and can be stored at room temperature. It withstands temperature fluctuations, reconstitutes rapidly, and ships in a plastic bag rather than a glass bottle, cutting the risk of breakage in transit. The FDA expects those features to make the product practical in austere environments where cold-chain storage and laboratory infrastructure are limited.
“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,” Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Ezplaz is prepared from a single unit of fresh frozen plasma collected at FDA-licensed blood establishments. It is offered in Group AB and Group A with low-titer anti-B types — blood types selected to reduce the risk of transfusion reactions when a patient’s blood type has not yet been determined. Each kit is self-contained, containing one unit of 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.
The FDA said its review found that, for the approved uses under the license, the benefits of Ezplaz outweigh the risks, with a safety profile consistent with other plasma products used for transfusion.
The licensure caps a push begun in December 2017, when Public Law 115-92 authorized the Pentagon-FDA collaboration to expedite development of products for life-threatening conditions facing U.S. military personnel. Freeze-dried plasma was among the first candidates identified, and the agency issued guidance for dried plasma manufacturers in 2019.
“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 agency’s Office of Blood Research and Review.
Source: FDA Press Announcement
