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Genzyme Fabrazyme

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Enrollment for Phase IV study of the enzyme replacement therapy Fabrazyme (agalsidase beta) for Fabry disease will begin in January following receipt of "complete review" letter Dec. 22. FDA "requested clarification of several points, identified additional data it needs, and emphasized the importance of initiating the planned Phase IV clinical study," Genzyme said. Transkaryotic Therapies' Replagal (agalsidase alpha) is also receiving priority review at FDA for Fabry disease (1"The Pink Sheet" Dec. 18, 2000, p. 34)
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