FDA Approves Protalix’s Treatment Protocol For prGCD

FDA has approved Protalix BioTherapeutics’ treatment protocol for prGCD, the proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD), for the treatment of Gaucher disease.

The treatment protocol allows physicians and other care-providers to treat patients of Gaucher disease with prGCD in the US and world-wide. The studies of prGCD are a part of the company’s ongoing pivotal phase III clinical trial. Prior to accepting the protocol, the FDA reviewed available data from the company’s on-going phase III clinical development programs.

The treatment protocol is a multicenter, open-label trial designed to allow physicians and other care-providers to treat patients of Gaucher disease with prGCD, during the expected shortage of Cerezyme and thereafter.

Cerezyme is a mammalian cell expressed version of glucocerebrosidase and the only enzyme replacement therapy currently approved for Gaucher disease.

David Aviezer, president and chief executive officer of Protalix, said: We appreciate the guidance and vote of confidence provided by the FDA in establishing a treatment protocol for prGCD and are working closely with physicians and patient advocacy groups to allow Gaucher disease patients to gain access to our drug. We expect to conclude our phase III pivotal study next month and are looking forward to announcing top-line results from this study in October. We anticipate filing an NDA with the FDA by the end of this year.”