FDA approves Wyeth's hemophilia A drug

The US Food and Drug Administration has approved drug major Wyeth's treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the USA. The new treatment, called Xyntha antihemophilic factor (recombinant), is a genetically-engineered version of factor VIII, a protein essential for the clotting of blood that is missing or decreased in patients with hemophilia A.

The agent 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, and is also approved to help prevent surgical bleeding in this patient population.

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, noted the FDA. "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, director of the FDA's Center for Biologics Evaluation and Research.