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Genzyme Fabrazyme

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Company presented results of its pivotal Phase III study in 58 patients with Fabry disease at the American Society of Human Genetics meeting in Philadelphia Oct. 5. Twenty of 29 patients treated every two weeks for 20 weeks with intravenous agalsidase beta achieved a score of zero on a scale of 0-3 measuring the level of GL-3 in the kidney vasculature. The score indicated that patients' "blood vessels were restored to a near normal state," providing "strong evidence that the kidney should function normally as a result of treatment," the company said. Genzyme expects approval for its BLA, submitted June 23, around the end of the yea

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