FDA Approves Protalix Protocol With Cerezyme in Short Supply

The FDA has approved the treatment protocol for Protalix BioTherapeutics to test prGCD, its experimental medicine for Gaucher’s disease, and the company plans to file an NDA by the end of the year. Genzyme recently announced a shortage of the only approved treatment for Gaucher’s disease, Cerezyme (imiglucerase), after a temporary production halt due to viral contamination at the company’s Allston, Mass., plant. As a result, the FDA asked Shire and Protalix in July to submit treatment protocols for their experimental Gaucher’s disease medicines.
Washington Drug Letter