Baxter Healthcare Corporation Receives FDA Approval for 3000 IU Dosage Strength of Advate(R) for Hemophilia A
"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.
About ADVATE
ADVATE is currently approved for use in the United States, Canada, Australia, Japan and Europe.
ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and for perioperative management. ADVATE is not indicated for the treatment of von Willebrand disease. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to properly function. ADVATE is the only recombinant factor VIII therapy processed without blood or blood additives, including human albumin or other plasma protein additives.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing.
Patients and caregivers in the United States can obtain more information on ADVATE, including full Prescribing Information at http://www.advate.com.
About BAXJECT II
The BAXJECT II device is intended for use with a single vial of product and is for single use only. Therefore, reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device. Rx only. For safe and proper use of this device, please refer to the Instructions for Use at http://www.baxjectii.com.
About hemophilia A
People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. If untreated, patients with severe hemophilia A have a greatly reduced life expectancy. According to the World Health Organization, more than 400,000 people in the world have hemophilia, corresponding to a prevalence of 15 to 20 in every 100,000 males born worldwide.
Baxter Research and Development
Baxter focuses its scientific resources and leverages strategic collaborations to advance the treatment of hemophilia and blood clotting disorders. Building on its history of innovation, the company is developing therapies to provide less invasive dosing techniques, require less frequent infusions, and/or reduce the potential for inhibitor formation to improve the lives of people with bleeding disorders.
About Baxter
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
* As compared to original BAXJECT and needles
** Number of patients prescribed ADVATE is growing everyday as per
provider database on file at Baxter Healthcare Corporation