Shire plc (SHPGY) Submits License Application for REPLAGAL®
Shire plc, a global specialty biopharmaceutical company, today announced that it has submitted a Biologics License Application (BLA) with the FDA for REPLAGAL®, the company’s enzyme replacement therapy for Fabry disease. REPLAGAL first received marketing authorization in the EU in 2001, and is approved for the treatment of Fabry disease in 45 countries. Fabry disease is a rare X-linked recessive (inherited) lysosomal storage disease that can cause a wide range of systemic symptoms. The disease interferes with the body's ability to break down a specific fatty substance (globotriaosylceramide or Gb3) which accumulates within the body due to deficiency of a…