FDA approves Baxter's Ultra-High dosage strength of Advate for hemophilia A

By Lisa Kerner

Erie, Pa., May 9 - The Food and Drug Administration has approved Baxter Healthcare Corp.'s new 2000 IU (5 mL) Ultra-High dosage of Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method(rAHF-PFM)).

Advate is the only therapy free of blood-based additives used for the prevention and control of bleeding episodes in people with hemophilia A, according to a company news release.

With the approval of the ultra-high dosage strength, Advate factor VIII therapy is available in five different dosage strengths: low (250 IU), medium (500 IU), high (1000 IU), super-high (1,500 IU) and ultra-high (2,000 IU).

Baxter said the ultra-high dosage strength vial reduces both the infusion volume of drug solution and the storage space. The therapy will be available to patients in the United States by the end of May.

According to the World Health Organization, more than 400,000 people in the world have hemophilia, a condition in which the blood does not effectively clot due to inadequate amounts of factor VIII.

Baxter Healthcare is the principal U.S. operating subsidiary of Baxter International Inc., a medical device, pharmaceutical and biotechnology company based in Deerfield, Ill.

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