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Transkaryotic Therapies Replagal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A pivotal Phase II trial in 26 patients with Fabry disease showed a mean reduction in severe, debilitating pain for patients receiving 20- to 40-minute agalsidase alfa infusions every other week for six months compared to placebo patients. Results were presented at the American Society of Human Genetics meeting. TKT expects approval of the BLA, submitted June 16, at the end of the yea
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