Protalix Obtains FDA Fast Track Designation For prGCD

Protalix has received Fast Track Designation from the FDA for prGCD, the company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD). It is intended for the treatment of Gaucher disease.

Reportedly, Protalix plans to submit the first section of the rolling NDA for prGCD, allowed under the Fast Track process.

The company expects to complete phase III trial of prGCD 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 also 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.