Wyeth Pharmaceuticals, a division of Wyeth, has received approval from the US Food and Drug Administration for Xyntha (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with haemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis.
Xyntha 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 haemophilia 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 haemophilia."
The safety and efficacy of Xyntha in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with haemophilia A has been demonstrated in pivotal clinical trials.
Haemophilia A is a rare, inherited blood-clotting disorder. People with haemophilia A are deficient in a key protein factor VIII which is vital in the clotting mechanism to prevent bleeding. Haemophilia A can be characterized by spontaneous haemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with haemophilia A are dependent on factor VIII replacement therapy.
Xyntha Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with haemophilia A and for surgical prophylaxis in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia).