Chiesi Global Rare Diseases, Protalix Say ELFABRIO Approved By FDA For Fabry Disease

(RTTNews) - Chiesi Global Rare Diseases, a unit of the Chiesi Group and Protalix BioTherapeutics, Inc. (PLX) Wednesday said the U.S. Food and Drug Administration (FDA) has approved ELFABRIO (pegunigalsidase alfa-iwxj) for the treatment of adult patients with Fabry disease.

Fabry disease is a genetic disorder caused by deficiency of the enzyme alpha-galactosidase-A, resulting in abnormal deposits of fats throughout a person's body.

ELFABRIO is a PEGylated enzyme replacement therapy (ERT). It is a recombinant human a-Galactosidase-A enzyme expressed in plant-cell culture that is designed to provide a long half-life, the company said.