Protalix BioTherapeutics, Inc.
FDA Grants Protalix Orphan Drug Designation for prGCD
Published in FDA Law Weekly, September 24th, 2009
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA's Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company's proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. Gaucher disease is a lysosomal storage disorder resulting from a deficiency or mutation of the GCD enzyme that can cause damage to the liver, spleen, bone marrow and in some cases, the central nervous system.
The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over...
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Source: FDA Law Weekly (2009-09-24)
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