Abstract:ADVATE rAHF-PFM was licensed by the FDA in 2003 and the EMEA in 2004 based on studies of previously treated patients (PTPs) with FVIII levels ≤2%. Subsequent to licensure, a PASS program was launched to document rAHF-PFM experience during the first year of routine therapy in subjects with FVIII baseline levels ≤5%, irrespective of prior FVIII exposure or inhibitor history. As of May 25, 2007, a total of 537 subjects (519 male, 2 female, 16 unreported) were enrolled. Of these 537 subjects, 67 were previously un… Show more
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