Wyeth’s XYNTHA Approved by FDA for Treatment of Hemophilia A
XYNTHA represents important improvements in product purification technology −
Collegeville, Pa.— Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it has received approval from the U.S. Food and Drug Administration for XYNTHA™ (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.
XYNTHA™ 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.
Important Safety Information
* Allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs or symptoms of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, and hypotension] and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physicians if these symptoms occur.
* Inhibitors have been detected in patients receiving factor VIII containing products. In a pivotal phase 3 study, two of 89 patients (2.2 percent) who completed 50 exposure days developed factor VIII inhibitor. These results were consistent with the pre-specified endpoint of the study. Patients using coagulation factor VIII products, including XYNTHA, should be monitored for the development of factor VIII inhibitors. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
* XYNTHA contains trace amounts of hamster proteins. Patients treated with this product could develop hypersensitivity to these nonhuman mammalian proteins.
* When clinically indicated, patients should have plasma factor VIII activity levels monitored by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained.
* The most frequently reported adverse reactions in clinical studies were headache and fever.
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