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.

Transplanted liver cells show promise for Hemophilia Cure

I've been late in linking to this important and hopeful bit of news.

The meat of the find:

In the study, Gupta's team worked with a mouse model of hemophilia. They transplanted healthy liver endothelial cells into the livers of these mice, according to the report in the Feb. 14 online issue of the Journal of Clinical Investigation.

Three months after transplanting the cells, the number of healthy cells had increased and were producing factor VIII in amounts sufficient to cure their hemophilia, the researchers found.

Given these results, researchers can start to focus on where factor VIII is made in the human body and how things can go wrong with its production, Gupta said. (emphasis mine)