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Protalix Gaucher Drug Gets Fast Track

Protalix BioTherapeutics, Inc. received Fast Track Designation from the FDA for prGCD, a plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Protalix BioTherapeutics, Inc. received Fast Track Designation from the FDA for prGCD, a plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

Fast Track designation facilitates the development and expedites the review of drugs to treat serious diseases. It enables the agency to process the NDA on a rolling basis as sections are completed and submitted for review.

The company expects to complete its Phase III trial of prGCD for the treatment of Gaucher’s disease in September, have results by October, and to complete its NDA before the end of the year. Also, the company has initiated a treatment protocol that allows physicians to treat Gaucher disease patients while the drug is still under investigation.

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