Wyeth receives FDA license for new Factor VIII product

The U.S. Food and Drug Administration today licensed a new treatment for hemophilia A called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free. Xyntha is manufactured by Philadelphia-based Wyeth Pharmaceuticals Inc. Xyntha joins BeneFIX (hemophilia B) and ReFacto (hemophilia A) in Wyeth's antihemophilic lineup.

From the FDA release:

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.