Teleflex receives FDA BLA approval for EZPLAZ Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product for emergency bleeding and trauma care.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Teleflex Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted Biologics License Application (BLA) approval for EZPLAZ™ Freeze Dried Plasma (FDP). The product is approved for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled bleeding (hemorrhage), when plasma is required and other plasma products are not available. The approval marks the first freeze-dried plasma licensed by the FDA and the first biologics license for a blood component received by Teleflex.
Addressing Emergency Hemorrhage
Hemorrhage is the leading cause of preventable death among both battlefield and civilian trauma patients. Although plasma products provide essential clotting proteins for managing hemorrhage and coagulopathy, conventional plasma is difficult to use in emergency settings because it requires frozen storage, thawing equipment, and refrigeration after thawing.
Jake Newman, President and General Manager of Global Vascular and Emergency Medicine at Teleflex, said EZPLAZ™ FDP could expand access to plasma transfusions in ambulances, hospitals, and battlefield settings. Unlike current Emergency Use Authorization freeze-dried plasma products supplied in glass bottles, EZPLAZ™ FDP uses a patented flexible plastic bag designed to improve portability and ease of use.
Defense Health Agency Collaboration
Recognizing the need for an FDA-approved freeze-dried plasma product, the U.S. Defense Health Agency (DHA) prioritized its development. In 2014, Vascular Solutions LLC, a wholly owned Teleflex subsidiary, entered into a Cooperative Research and Development Agreement (CRADA) with the team now known as Warfighter Protection and Acute Care (WPAC), part of the DHA.
According to Dr. Kendra Lawrence, WPAC Project Manager, the program works with industry partners to develop mission-critical medical technologies and emphasized the importance of shelf-stable, easy-to-transport blood products for frontline emergency care.
Product Features
Teleflex led product development and established manufacturing operations supporting the Investigational New Drug (IND) application. EZPLAZ™ FDP is supplied as a kit containing all components required for transfusion, including Sterile Water for Injection (SWFI) for reconstitution.
The product can be stored at 2°C to 25°C (36°F to 77°F), has a 12-month shelf life, and can be reconstituted in approximately 1 to 2.5 minutes, making it suitable for emergency situations where rapid plasma availability is essential.
Approved Indications and Safety
EZPLAZ™ FDP is indicated for adults requiring plasma when alternative plasma products are unavailable. Approved uses include replacement of multiple plasma coagulation factors in bleeding or preoperative patients, management of clinically significant coagulation deficiencies during massive transfusion, and temporary reversal of warfarin anticoagulation in patients with bleeding or those requiring urgent invasive procedures.
The product is contraindicated in patients with hypersensitivity to plasma-derived products or IgA deficiency. Potential risks include hemolytic transfusion reactions, transfusion-related acute lung injury (TRALI), transmission of infectious agents, and hypersensitivity reactions, including anaphylaxis. To reduce TRALI risk, the product is manufactured using plasma from male-only donors. Teleflex also notes that EZPLAZ™ FDP is not intended for routine volume expansion and that targeted coagulation therapies should be considered when clinically appropriate.
Advancing Trauma Care
Christopher Ross, MD, Global Medical Safety Director and Interim Head of Clinical and Medical Affairs at Teleflex, said the company’s clinical development program generated the evidence supporting the safety and effectiveness of EZPLAZ™ FDP while acknowledging the contributions of investigators, blood donors, study participants, and government partners.
The FDA approval of EZPLAZ™ FDP introduces the first FDA-licensed freeze-dried plasma product in the United States, expanding access to shelf-stable plasma for trauma, emergency, prehospital, and military care where conventional plasma products may not be readily available.
Reference
Teleflex – Teleflex Announces FDA BLA Approval of EZPLAZ™ Freeze Dried Plasma
FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S. | FDA
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.