Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new 3000 IU (5mL) dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method].
ADVATE is used for the prevention and control of bleeding episodes in people with hemophilia A and is the only factor VIII therapy free of blood-based additives. The new 3000 IU dosage strength vial makes it easier and faster for people requiring higher doses to administer ADVATE by decreasing the number of vials needed and reducing their total infusion volume. The ADVATE 3000 IU vial is also packaged with BAXJECT II for faster and easier mixing*. The dosage strength will be available to patients in the United States beginning in August 2007.
"The 3000 IU is ideal for me," said Seth Rye, a patient with hemophilia A. "I now only have to use one vial to dose myself, and if you combine the 3000 IU with BAXJECT II, I've reduced my usual treatment time in half which is great."
As each person with hemophilia A has different needs when it comes to infusions, it is important to have a variety of dosage strengths from which to choose. With the approval of the 3000 IU (5mL) dosage strength, ADVATE is the only factor VIII therapy to offer people with hemophilia A in the United States such a broad selection of dosage strengths: 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU.
"The new 3000 IU dosage strength vial will offer people with hemophilia A more flexibility in incorporating ADVATE into their therapeutic routines," said Larry Guiheen, president, North America region, Baxter Bioscience. "Baxter is committed to expanding the ADVATE product line in order to streamline the process of infusion for patients, allowing it to fit more easily into their lives."
Since its introduction in 2003, ADVATE is the therapy more patients are choosing every day**. With over two billion units of ADVATE distributed worldwide, ADVATE has been shown to be safe and effective in both clinical studies and in the real world.
The full marketing approval of ADVATE 3000 IU is anticipated in Europe in 2008.