Recombinant Factor VIII gets FDA nod

February 28, 2008

Recombinant antihemophilic Factor VIII approved by FDA.

approval by the Food & Drug Administration for the control and prevention of bleeding in patients with hemophilia A. The antihemophilic factor product is manufactured using recombinant DNA techniques with genes from Chinese Hamster Ovary cells that are modified to produce Factor VIII. According to Wyeth, the culture in which the cells are grown is free of any human or animal material, and is plasma- and albumin-free, which minimizes the risk of infection. During drug studies, two of 89 patients who underwent 50 days of treatment with Xyntha developed Factor VIII inhibitors, antibodies that counteract treatment. The most frequently reported side effect was headache. When the product was used during surgery, the most common adverse reaction was fever.

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