Teleflex Incorporated has received Biologics License Application (BLA) approval from the US Food and Drug Administration (FDA) for Ezplaz Freeze Dried Plasma (FDP), marking the first FDA-licensed freeze-dried plasma product in the United States. The approval also represents the company's first biologics licence for a blood component.

Ezplaz FDP is approved for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled haemorrhage, when plasma is required but other plasma products are unavailable. The product is expected to expand access to plasma transfusions in emergency situations where conventional frozen plasma is difficult to use due to storage and transportation limitations.

Unlike existing freeze-dried plasma products available under Emergency Use Authorization, which are packaged in glass bottles, Ezplaz FDP uses Teleflex's patented flexible plastic bag technology. The product is designed for use across a wide range of emergency care settings, including hospitals, road and air ambulances and military battlefields.

Jake Newman, President and General Manager, Global Vascular and Emergency Medicine at Teleflex, said the approval represents a significant milestone for both healthcare providers and the company. He noted that the innovative packaging and rapid deployment capabilities of Ezplaz FDP could enable timely plasma transfusions in situations where immediate treatment is critical.

Haemorrhage remains one of the leading causes of preventable death among both civilian trauma patients and military personnel. Although plasma products play a vital role in controlling severe bleeding and correcting coagulation disorders, the use of conventional plasma is often limited outside hospital settings due to the need for frozen storage, lengthy thawing times and refrigerated handling after thawing.

Recognising these challenges, the US Defense Health Agency (DHA) prioritised the development of an FDA-approved, commercially available freeze-dried plasma product. In 2014, Vascular Solutions LLC, a wholly owned subsidiary of Teleflex, entered into a Cooperative Research and Development Agreement (CRADA) with the DHA's Warfighter Protection and Acute Care (WPAC) programme to support the product's development..

Teleflex led product development and established manufacturing operations to support the Investigational New Drug (IND) application and subsequent regulatory approval. Ezplaz FDP is supplied as a complete transfusion kit, including Sterile Water for Injection for rapid reconstitution. The product can be stored at 2°C to 25°C, has a 12-month shelf life, and can be reconstituted in approximately 1 to 2.5 minutes, making it well suited for emergency and prehospital care.

The FDA-approved indications include treatment of patients requiring replacement of multiple plasma coagulation factors, including those with liver disease or disseminated intravascular coagulation (DIC), patients undergoing massive transfusions with significant coagulation deficiencies, and patients receiving warfarin who require urgent reversal due to bleeding or invasive procedures.