Teleflex receives US FDA approval for Ezplaz Freeze Dried Plasma

Teleflex Incorporated, a leading global provider of medical technologies, announced it has received Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma (FDP) from the US Food and Drug Administration (FDA). Ezplaz FDP is approved for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled bleeding (haemorrhage), when plasma is required and other plasma products are not available. This landmark approval is the first freeze dried plasma licensed by the FDA, and the first biologics license for a blood component for Teleflex.

“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. “While current Emergency Use Authorization FDP products use glass bottles as containers, Ezplaz FDP utilizes a patented flexible plastic bag technology. The BLA approval of Ezplaz FDP is a critical milestone for our customers and for Teleflex, as we continue to expand our emergency medicine portfolio.”

Haemorrhage is the leading cause of preventable death for both battlefield and civilian trauma patients. Plasma products contain proteins that help clot blood and can be used for the management of haemorrhage and coagulopathy. However, the use of traditional plasma products in combat and prehospital settings is limited by logistical and operational challenges, such as the need for freezers and thawing equipment, a long thawing period, and post thaw refrigeration requirements.

Based on this clinical challenge, the Defense Health Agency (DHA) has made the development of an FDA-approved, commercially available source of freeze dried plasma a top priority. In April 2014, Vascular Solutions LLC (a wholly owned subsidiary of Teleflex) entered a Cooperative Research and Development Agreement (CRADA) with the team now known as Warfighter Protection and Acute Care (WPAC), which is part of DHA.

"The WPAC Program Management Office partners with companies to develop products to address the Department of War’s mission-critical medical priorities,” said Dr. Kendra Lawrence, WPAC’s project manager. “Warfighter emergency medical care relies, in part, on bringing shelf-stable and easy to transport blood products to the front lines of the battlefield where they are most needed.”

“The approval of Ezplaz FDP marks an important milestone in the availability of freeze-dried plasma in the United States,” said Christopher Ross, MD, global medical safety director and interim head of clinical and medical affairs at Teleflex. “Our clinical development program was designed to generate the evidence needed to support the safety and effectiveness of Ezplaz FDP for its approved indication. We are grateful to the investigators, blood donors, study participants, and our government partner whose collaboration made this achievement possible.”

Teleflex has been responsible for product development and establishing manufacturing operations to support the submission of the Investigational New Drug (IND) application. The freeze dried unit of plasma is kitted with components needed for transfusion, including Sterile Water for Injection (SWFI) for the initial reconstitution step. The product has a storage temperature of 2 to 25°C (36 to 77°F), a 12-month shelf life, and can be reconstituted in about 1-2.5 minutes.

Ezplaz Freeze Dried Plasma (FDP) is indicated for transfusion in adults when plasma is required and other plasma products are not available. Indications include:

• Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors [e.g., liver disease, disseminated intravascular coagulation (DIC)]
• Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
• Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect