Pfizer Inc. announced that the US Food and Drug Administration (FDA) has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of Xyntha Antihaemophilic Factor (Recombinant) Plasma/Albumin-Free to haemophilia A patients. Xyntha is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia) and for surgical prophylaxis in patients with haemophilia 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 haemophilia 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 haemophiliaaaa 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 haemophilia 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 Haemophilia and Thrombosis Center. "As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with haemophilia A convenience in reconstituting Xyntha, potentially saving them both time and effort."

Xyntha is a recombinant factor VIII product approved by the FDA in February 2008 for both the control and prevention of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia) and for surgical prophylaxis in patients with haemophilia A. Xyntha does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease. Xyntha uses a state-of-the-art manufacturing and purification process that is completely albumin-free, from cell culture to final formulation.

Xyntha is the only recombinant factor VIII product using a synthetic peptide ligand in lieu of a mouse monoclonal antibody (Mab) in the purification process. It is designed to eliminate the potential risk of murine viral contamination. The purification process also includes a solvent detergent viral inactivation step and a nanofiltration step. These manufacturing and purification processes are designed to reduce the risk of potential viral contamination.