The Food and Drug Administration has licensed the first freeze-dried plasma product for use in the United States. The product could give patients in rural areas, combat zones and disaster settings faster access to lifesaving blood products.
The product is called Ezplaz Freeze Dried Plasma. It is intended for adults who need plasma when conventional plasma products are not available. The FDA licensed Ezplaz on July 29.
Ezplaz can be used for patients who are bleeding or require massive transfusions. It can also be used for certain patients taking warfarin who are experiencing bleeding.
Conventional plasma must be kept frozen and thawed before it can be given to a patient. Ezplaz can instead be stored at room temperature. It can also withstand temperature fluctuations and be rapidly prepared for transfusion.
Those features could make the product particularly useful in rural communities. Hospitals and blood banks may be far away in those areas. It could also be used during military operations and disaster responses where refrigeration and other hospital 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,” said Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research.
Ezplaz is also packaged in a plastic bag instead of a glass bottle. The FDA said this reduces the risk of breakage during transportation and handling.
Each kit contains one unit of freeze-dried plasma and a 250-milliliter bag of sterile water. It also includes a sterile fluid transfer set and a blood transfusion set. The components are packaged together so the product can be prepared where it is needed.
The plasma is produced from a single unit of fresh frozen plasma. It is collected from an FDA-licensed blood establishment. Ezplaz is available in Group AB and Group A with low-titer anti-B blood types.
Those blood types were selected to reduce risks during emergencies. They can be given before a patient’s blood type is determined.
The FDA said the safety profile of Ezplaz is consistent with other plasma products used for transfusions. The agency determined that its benefits outweigh the risks when used for approved indications.
Development of dried plasma products has also been a priority for the U.S. military. Freeze-dried plasma was among the first products identified under a law enacted in 2017.
The law authorized collaboration between the Department of Defense and the FDA. The effort was intended to speed the development and review of products for serious or life-threatening conditions affecting military personnel. The FDA later issued guidance for manufacturers developing dried plasma products in 2019.
The biologics license for Ezplaz was granted to Vascular Solutions, LLC. The company is a subsidiary of Teleflex.