FDA approves Baxters ADVATE for the treatment of he...( ssing or add human albumin for stabili...),Health

ssing, or add human albumin for stabilization. These components have the potential to carry disease-causing viruses or pathogens, such as HIV, West Nile Virus or variant Creutzfeldt-Jakob Disease (vCJD), the human form of mad cow disease. The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation has issued formal recommendations (#141) advising that "all efforts should be made to remove human albumin from recombinant factor VIII products" and " increased efforts should be made to eliminate human and bovine proteins from the manufacturing process of recombinant products." ADVATE is the first and only FDA-approved factor VIII therapy to meet these guidelines.

"During the last 40 years, Baxter has strived continually to provide the hemophilia community with enhanced, safer factor VIII therapeutics. The FDA approval of ADVATE marks another important milestone for Baxter and the hemophilia community," said Thomas Glanzmann, president, Baxter BioScience. "Baxter is pleased to have consistently met the needs of the hemophilia community by introducing innovative technology to elevate the standard of care."

ADVATE CLINICAL DATA

Phase II-III clinical trials evaluated the safety, immunogenicity and efficacy of ADVATE in the treatment and prevention of bleeding in previously treated hemophilia patients in a variety of clinical settings. Data demonstrate that ADVATE has equivalent pharmacokinetic properties to RECOMBINATE, and is effective in controlling bleeding episodes, which can occur as often as three times per month in patients with severe hemophilia A.

"The development of ADVATE is based on our scientific expertise and application of innovative technologies to advance the treatment of hemophilia," said Norbert Riedel, Ph.D., chief scientific officer, Baxter. "ADVATE is the first and only factor VIII therapy that combines the unsurpassed pathogen safety of a plasma/albumin-free method with the proven ef
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Contact: Cindy Resman, BAXTER
847-948-2815
Porter Novelli
28-Jul-2003

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