FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Adult Patients with Fabry Disease
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®, have announced that the U.S. Food and Drug Administration (FDA) has approved Elfabrio (pegunigalsidase alfa-iwxj) in the United States for the treatment of adult patients with Fabry disease.
Elfabrio is a PEGylated enzyme replacement therapy (ERT). It is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life. The recommended dosage of Elfabrio, based on actual body weight, is 1 mg/kg administered by intravenous infusion every 2 weeks.
