Wyeth Pharmaceuticals, a division of Wyeth has announced that it has received approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis.
XYNTHA (pronounced "ZIN-tha") is manufactured using a completely albumin-free process and state- of-the-art nanofiltration purification technology. In addition, XYNTHA is the only recombinant factor VIII product to utilize an entirely synthetic (non- human and non-animal based) purification process in its manufacture.
Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "This is another example of Wyeth's continued commitment to the advancement of science in the treatment of hemophilia."
The safety and efficacy of XYNTHA in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with hemophilia A has been demonstrated in pivotal clinical trials.
About Hemophilia A
Hemophilia A is a rare, inherited blood-clotting disorder. People with hemophilia A are deficient in a key protein -- factor VIII -- which is vital in the clotting mechanism to prevent bleeding. Hemophilia A can be characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with hemophilia A are dependent on factor VIII replacement therapy.
Indication
XYNTHA(TM) Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.