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Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Replagal seemed destined for quick approval – the enzyme replacement therapy was already distributed free of charge to U.S. patients in response to short supples of Genzyme’s Fabrazyme. But FDA has signaled otherwise, and Shire doesn’t think Replagal warrants the effort.

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