By Siddhi Mahatole
July 29 (Reuters) – The U.S. FDA on Wednesday approved the first freeze-dried plasma product for use in the country, providing an option for patients when conventional plasma is unavailable.
The agency granted a biologics license to Vascular Solutions — a subsidiary of Teleflex — for Ezplaz Freeze Dried Plasma, which is indicated for adult patients who require plasma transfusions when other plasma products are unavailable.
The approval comes as the American Red Cross, one of the largest U.S. suppliers of blood products, grapples with a national blood supply crisis, only the second in its history.
The organization said on Monday that donations have fallen to a four-year summer low, leaving it with less than a one-day national supply of O positive blood and forcing limits on shipments to some hospitals.
Dr. Pampee Young, chief medical officer of the American Red Cross, said the approval is unlikely to significantly ease the blood shortages most often faced by U.S. hospitals.
“Moreover, blood shortages in the United States most often affect red blood cells and platelets rather than plasma. Therefore, this approval is unlikely by itself to materially alleviate the blood-component shortages hospitals experience most frequently,” Young told Reuters.
Unlike conventional plasma, which must be stored frozen and thawed before use, Ezplaz can be stored at room temperature and rapidly reconstituted.
The product is packaged in a plastic bag rather than a glass bottle, making it easier to transport and less vulnerable to breakage.
The FDA said the product could improve access to plasma for patients with life-threatening bleeding in combat zones, disaster-response operations and rural areas with limited hospital infrastructure.
Ezplaz is derived from a single unit of fresh frozen plasma collected at FDA-licensed blood establishments and is available in Group AB and Group A low-titer anti-B blood types for emergency use before a patient’s blood type is known.
(Reporting by Siddhi Mahatole and Padmanabhan Ananthan in Bengaluru; Editing by Maju Samuel)
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