Healthcare Industry News:  hemophilia A 

Biopharmaceuticals FDA

 News Release - May 9, 2006

Baxter Receives FDA Approval for Ultra-High Dosage Strength of ADVATE for Hemophilia A

New 2000 IU Dosage Strength Increases Ease of Use for People With Hemophilia

DEERFIELD, Ill., May 9 (HSMN NewsFeed) -- Baxter Healthcare Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved a new 2000 IU (5mL) Ultra-High dosage of ADVATEŽ [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM)], the only therapy free of blood-based additives, used for the prevention and control of bleeding episodes in people with hemophilia A. The new Ultra-High dosage strength vial makes it easier for people requiring higher doses to administer ADVATE by reducing 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.

"It's always difficult to fit infusing into my daily schedule," said Seth Rye, a 21-year-old hemophilia A patient. "With its shorter infusion time and faster and easier mixing, the Ultra-High dosage strength of ADVATE allows me more time to focus on the activities I enjoy, like swimming."

As each person with hemophilia has different needs when it comes to their infusions, it is important for them to have a variety of dosage strengths from which to choose. With the approval of the Ultra-High dosage strength, ADVATE is now the only factor VIII therapy to offer people with hemophilia A in the United States five different dosage strengths: Low (250 IU), Medium (500 IU), High (1000 IU), Super-High (1500 IU) and Ultra-High (2000 IU).

"We heard from the community that there was a need for more choices in dosage strengths for hemophilia therapies," said Joy Amundson, president, Baxter's BioScience business. "Therefore, we are proud to offer the Ultra-High dosage strength of ADVATE, providing patients with one more reason to choose ADVATE, the therapy people with hemophilia have come to rely on."

Since its introduction in 2003, ADVATE is the therapy more patients are choosing every day. With over one billion units of ADVATE distributed, ADVATE has been proven to be safe and effective in both clinical studies and in the real world.

About ADVATE

ADVATE is currently approved for use in the United States, Australia and 14 countries in the European Union.

ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. 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 is also indicated in the perioperative management of patients with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand's disease.

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. The formation of inhibitors has been observed with all factor VIII concentrates, including ADVATE.

For more information on ADVATE including full prescribing information, please visit http://www.advate.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.

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.


Source: Baxter

Issuer of this News Release is solely responsible for its content.
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