FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.  XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.

"The approval of the Prefilled Dual-Chamber Syringe is an important milestone for hemophilia patients due to its innovative, convenient reconstitution system that eliminates the transfer step," said Emil Andrusko, vice president, marketing, Specialty Biologics at Pfizer Inc.  "Pfizer is committed to the hemophilia community not only through the development of novel reconstitution systems focusing on convenience, such as the XYNTHA Prefilled Dual-Chamber Syringe, but also through early clinical research of other proteins, including Factor Xa and Factor VIIa."  

The first Prefilled Dual-Chamber Syringe will provide 3000 IU of XYNTHA, the highest dose, in a low 4 mL volume.  Other dosages of XYNTHA will be available in the Prefilled Dual-Chamber Syringe in 2011.  The device is used to deliver XYNTHA by intravenous (IV) infusion after reconstitution of a freeze-dried powder with the diluent (0.9% Sodium Chloride).  For the first time, both the XYNTHA powder and the diluent are supplied within the Prefilled Dual-Chamber Syringe.

"For the hemophilia A patient who is always on-the-go, any treatment option that can enhance convenience is critical to the management of his health and lifestyle," said Sue Geraghty, RN, MBA, Nurse Coordinator, University of Colorado School of Medicine Hemophilia and Thrombosis Center.  "As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with hemophilia A convenience in reconstituting XYNTHA, potentially saving them both time and effort."