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7/29/2003

FDA Approves 1st Antihemophilic Factor Free of Blood Derivatives

Cheryl Thompson

The licensing of Advate (PDF), the first recombinant antihemophilic factor produced without plasma or albumin, was approved Friday by the Food and Drug Administration.

Baxter Healthcare Inc.'s newest hemophilia therapy is indicated for the prevention and control of bleeding episodes in persons with hemophilia A and also for the management of these patients before and after surgery.

The manufacturing process for Advate is similar to the process for making Recombinate, another recombinant antihemophilic factor by Baxter, but with two major differences: no plasma, albumin, or other substance from humans or animals is added during the manufacture of Advate, and a solvent–detergent step is used during the purification of Advate to inactivate viruses that might have been present in the culture medium in which the recombinant protein was made. The recombinant blood-clotting factor in both Baxter products is synthesized in transformed Chinese hamster ovary cells. Recombinate includes human serum albumin in the formulation to stabilize the protein.

Patients who have had a life-threatening immediate hypersensitivity reaction to Advate should not receive it again. According to the product's labeling, hypersensitivity to mouse or hamster proteins may be a contraindication to the use of Advate.

Hot flashes, dizziness, and a strange taste were the most commonly reported adverse events related to the receipt of Advate during the clinical studies.

The recommended doses of the plasma- and albumin-free product for treating hemorrhages are the same as for Baxter's older recombinant antihemophilic factor. Doses of Advate for patients undergoing surgery are as follows: tooth extraction and other minor procedures, sufficient product to achieve a peak factor VIII activity of 60–100 IU per deciliter of blood; major surgical procedures, sufficient product to achieve a peak factor VIII activity of 80–120 IU/dL before and after surgery. The frequency of infusing Advate in patients undergoing minor surgery differs from the frequency recommended for Recombinate.

According to the labeling, a dose of Advate should be administered in five minutes or less.

Baxter said it expects to start shipping its new product to distributors in three to six weeks.

Advate will be available in single-dose vials containing 250, 500, 1,000, or 1,500 IU of factor VIII activity and requiring storage at 2–8 degrees C. Each package will also contain a 5-mL vial of sterile water for injection and other supplies for administering the protein.

The product's labeling, unlike that for Recombinate, does not state that the components contain natural rubber latex.