Keywords: Shire, USA, Replagal, Velaglucerase, Fabry disease, Gaucher disease, BLA filing
Shire submits Replagal BLA with the USA’s FDA; recaps velaglucerase status
Article | 23 December 2009
Specialty biopharmaceutical company Shire says that it has submitted a Biologics License Application (BLA) with the USA’s Food and Drug Administration for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. The drug first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.
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