Shire Submits Biologics License Application (BLA) for REPLAGAL Withthe FDA

Tue, 12/22/2009 - 3:42am
Shire plc, a global specialty biopharmaceutical company, has submitted a BLA with the FDA for REPLAGAL(R)(agalsidase alfa), its enzyme replacement therapy for Fabry disease. REPLAGALfirst received marketing authorization in the European Union in 2001, and isapproved for the treatment of Fabry disease in 45 countries. REPLAGAL is currently available to U.S. Fabry patients under anFDA-approved treatment protocol, and the Company is also supporting emergencyIND requests. Shire worked closely with the FDA to establish an early accessprogram in response to the ongoing shortage of the currently marketedtreatment for Fabry disease in the U.S. "We continue to deliver on our commitment to the Fabry community byfiling a BLA to support long-term access to REPLAGAL in the United States,"said Sylvie Gregoire, President of Shire Human Genetic Therapies. "Weunderstand that this has been a difficult time for patients and we remaincommitted to doing all we can to support the Fabry community during thesupply shortage and for the long-term." Shire expects its REPLAGAL supply to be adequate to meet anticipatedglobal demand.

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