Shire PLC has withdrawn its application for U.S. approval of Fabry disease therapy Replagal (agalsidase alfa), a drug it has been supplying to patients free of charge while rival Genzyme Corp. struggles with shortages of its own therapy for the rare disease.
The decision was apparently spurred by Shire’s recent dialogue with FDA that suggested approval would be farther off than expected and therefore not worth the effort
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