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Baxter International, Inc. (BAX) Release: Real-World Experience Confirms Low Inhibitor Rate Established in ADVATE Controlled Clinical Studies for Hemophilia Patients


7/13/2010 10:18:25 AM

BUENOS AIRES, Argentina--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX) today announced final E.U./U.S. post-authorization safety surveillance (PASS) data that support the safety and efficacy profile of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] previously documented in prospective clinical trials in a new study published in the journal Haemophilia.1 Similar safety, inhibitor profile and efficacy were seen in previously treated patients (PTPs) with severe to moderately severe hemophilia A as well as across a broad range of hemophilia patients in everyday practice. The results are from the large, prospective, open-label, observational study examining 521 patients of any age and with severe to moderately severe hemophilia A who were treated prophylactically (preventatively) or on-demand (as needed) with ADVATE therapy at the discretion of the participating physicians in the United States and 11 countries in the European Union.

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