Teleflex wins FDA approval for first freeze dried plasma product

Teleflex Incorporated (NYSE: TFX) has received Biologics License Application approval from the U.S. Food and Drug Administration for EZPLAZ™ Freeze Dried Plasma, which the company claims is the first freeze dried plasma product licensed by the FDA.

The product is indicated for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled bleeding, when plasma is required and other plasma products are not available.

According to Teleflex, EZPLAZ™ uses a patented flexible plastic bag rather than the glass bottles used by existing freeze dried plasma products currently authorized under Emergency Use Authorization. The product has a storage temperature of 2 to 25°C, a 12-month shelf life, and can be reconstituted in approximately one to 2.5 minutes.

Teleflex entered a Cooperative Research and Development Agreement in April 2014 with the Defense Health Agency's Warfighter Protection and Acute Care program to develop the product. The Defense Health Agency had identified an FDA-approved, commercially available freeze dried plasma as a medical priority for battlefield use.

"EZPLAZ™ FDP can potentially enable the transfusion of plasma in situations where it is critically needed, including air and road ambulances, in the hospital, and on the battlefield," said Jake Newman, President and General Manager, Global Vascular and Emergency Medicine at Teleflex.

The product carries safety risks common to blood-derived products, including hemolytic transfusion reactions, transfusion-related acute lung injury, hypersensitivity reactions, and the potential transmission of infectious agents. It is contraindicated in patients with a history of hypersensitivity to plasma-derived products and in patients with IgA deficiency.

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