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FDA Approves Treatment Protocol for Use of Glucocerebrosidase NEW YORK -- August 17, 2009 -- The US Food and Drug Administration (FDA) has approved Protalix’s treatment protocol for the use of the plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The treatment protocol allows physicians and other providers to treat patients with Gaucher disease with GCD in the United States while studies of GCD continue. Prior to accepting the protocol, the FDA reviewed available data from on-going phase 3 clinical development programs. The treatment protocol is a multicentre, open-label trial designed to allow physicians and other providers to treat patients with Gaucher disease with GCD during the expected shortage of imiglucerase (Cerezyme) and thereafter. The treatment protocol allows patients enrolled in the protocol to continue being treated with GCD until its anticipated marketing approval from the FDA. SOURCE: Protalix BioTherapeutics E-mail this page to a friend or colleague! To print, use this version