Global specialty biopharmaceutical company Shire Plc (SHPGY, SHP.L) said it submitted a biologics license application or BLA with the U.S. Food And Drug Administration or FDA for Replagal or agalsidase alfa, its enzyme replacement therapy for Fabry disease.
Fabry disease is a lysosomal storage disorder that 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 specific enzyme, alpha-galactosidase A. The disease is usually expressed in males and diagnosed in nearly eight thousand to ten thousand people worldwide. It has a number of signs or symptoms of variable degree, such as cardiovascular and/or renal dysfunction, intense or burning pain, heat intolerance, skin lesions, gastrointestinal complaints, hearing loss, and ocular problems.
According to Shire, Replagal first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.
Replagal is currently available in the U.S. under an FDA-approved treatment protocol for Fabry disease, Shire indicated.
Additionally, Shire said it has submitted marketing applications for velaglucerase alfa, an enzyme replacement therapy in development for Type 1 Gaucher disease, in the U.S., EU and Canada. The application is being reviewed by the FDA under priority review.
SHPGY is trading at $57.43, up $0.03 or 0.05%, on a volume of about 99 thousand shares.
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