Pfizer Inc And Protalix BioTherapeutics Inc. Announce FDA Approval Of ELELYSO For Treatment Of Gaucher Disease

Pfizer Inc And Protalix BioTherapeutics Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. ELELYSO is the first FDA-approved plant cell-based ERT for Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx, Protalix's proprietary manufacturing system, using genetically engineered carrot cells. ELELYSO is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.