Protalix's Gaucher drug wins fast track designation

Wed. August 26, 2009; Posted: 09:49 AM

Aug 26, 2009 (Datamonitor via COMTEX) -- PXBT | Quote | Chart | News | PowerRating -- Protalix BioTherapeutics, a biopharmaceutical company, has received fast track designation from the FDA for prGCD, the company's proprietary plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.

Protalix plans to submit the first section of the rolling new drug application (NDA) for prGCD, allowed under 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 2009, to report top-line results in October and to complete the NDA filing before the end of 2009.

Additionally, the company has initiated a treatment protocol that allows physicians and other care-providers to treat Gaucher disease patients in the US and additional countries world-wide with prGCD while the drug is still under investigation.

Fast track designation is an FDA-approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier.

This process allows a company to file the sections of the NDA as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review.

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