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Protalix Receives FDA Fast Track Designation For PrGCD

August 26, 2009

Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the Company’sitting proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

Fast Track designation is an FDA approved course that facilitates the development and expedites the review of drugs to treat serious diseases and sate each unmet curative neediness with the goal of getting important new treatments to patients earlier. This projection allows a company to file the sections of the New Drug Application (NDA) as they grow available instead of filing all the sections at formerly. It also enables the procurement to commence its reviewal and proceed steady a rolling base as the extra sections are completed and submitted for critical notice. Protalix plans to lower one’s flag the first section of the rolling NDA for prGCD, allowed with less than the Fast Track process, in the very near future.

Protalix expects to complete the Company’s Phase III trial of prGCD for the treatment of Gaucher’s disease in September, to report top-line results in October and to complete the NDA filing before the end of the year. Additionally, the Company has initiated a treatment protocol that allows physicians and other care-providers to treat Gaucher illness patients in the United States and additional countries world-wide with prGCD while the put drugs into is still under investigation.

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Written by Samanta · Filed Under Pharmacy Industry News