Protalix Holds Pre-NDA Meeting with FDA for prGCD
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Protalix BioTherapeutics, Inc. announced has that the Company held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA).
The purpose of the meeting was to discuss the Company’s proposed new drug application (NDA) submission for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase, for the treatment of Gaucher disease and to confirm the clinical, nonclinical and chemistry requirements for the proposed NDA filing.
prGCD, the Company’s lead product candidate, is currently the subject of a pivotal Phase III clinical trial being conducted under the FDA’s Special Protocol Assessment (SPA) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.
"This meeting gives us confidence that we will be able to submit the NDA as planned and brings us one step closer to our goal of making prGCD commercially available to Gaucher disease patients through their treating physicians," said Dr. David Aviezer, President and Chief Executive Officer. "We look forward to announcing the results of our ongoing pivotal Phase III clinical trial for prGCD in the fourth quarter of 2009 and anticipate submitting the NDA before the end of the year."
The purpose of the meeting was to discuss the Company’s proposed new drug application (NDA) submission for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase, for the treatment of Gaucher disease and to confirm the clinical, nonclinical and chemistry requirements for the proposed NDA filing.
prGCD, the Company’s lead product candidate, is currently the subject of a pivotal Phase III clinical trial being conducted under the FDA’s Special Protocol Assessment (SPA) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.
"This meeting gives us confidence that we will be able to submit the NDA as planned and brings us one step closer to our goal of making prGCD commercially available to Gaucher disease patients through their treating physicians," said Dr. David Aviezer, President and Chief Executive Officer. "We look forward to announcing the results of our ongoing pivotal Phase III clinical trial for prGCD in the fourth quarter of 2009 and anticipate submitting the NDA before the end of the year."
