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TKT Replagal "complete review"

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Transkaryotic Therapies receives "complete review" letter Nov. 22 for its Fabry disease therapy Replagal (agalsidase alfa). FDA has continuing concerns regarding efficacy with the enzyme replacement therapy and will seek input from the Endocrinologic & Metabolic Drugs Advisory Committee Jan. 14. Preliminary results from an 80-patient Phase III trial did not show a statistically significant difference from placebo for the primary renal function endpoint. TKT suggests six months was not long enough to show renal benefi

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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