Xyntha, New Hemophilia Treatment Licensed By FDA

FOR IMMEDIATE RELEASE February 21, 2008

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FDA Licenses New Hemophilia Treatment

The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.

Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.

"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.

In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.

Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.

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