WIKIMEDIA COMMONS, KANDER
This week (May 1), the US Food and Drug Administration approved the first drug for humans produced by a genetically modified plant. Made by Israeli biotech Protalix Biotherapeutics and licensed in the US by Pfizer, Elelyso is an enzyme replacement therapy for Gaucher disease, a rare genetic disorder in which individuals do not produce enough of an enzyme called glucocerebrosidase, resulting in the buildup of fatty materials in the spleen, liver, and other organs.
Pfizer and Protalix had already made Elelyso available to some Gaucher disease patients as part of an early access program after Genzyme, maker of Cerezyme, a glucocerebrosidase-enzyme replacement product produced in hamster cells, experienced manufacturing delays due to contamination in its Massachusetts plant. Now, using genetically modified carrot cells, Pfizer and ...
