Fabrazyme confirmatory results
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genzyme plans to submit results of the principal confirmatory Phase IV study for its Fabry disease therapy Fabrazyme "for labeling purposes early next year," the firm says Sept. 9. A summary study report will be submitted in September. Fabrazyme (agalsidase beta) received accelerated approval for the orphan disease April 24, 2003. According to a preliminary analysis, of the 82 patients enrolled in the double-blind study, those receiving Fabrazyme were 53% less likely than placebo to experience a precursor disease event (p=0.058). Data will be presented at medical meetings in October, including the American Society of Nephrology. The firm is conducting another Phase IV verification study, due to FDA by April 2006...