Fabry Disease Treatment Showdown: Protalix Bio's Elfabrio Joins the Ranks of Sanofi and Amicus Therapeutics

The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's PLX Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with Fabry disease.

The product is an enzyme replacement therapy for adults with a rare, inherited disease in which abnormal deposits of fatty substances build up and cause pain and sometimes end-organ failure.

Elfabrio is a PEGylated enzyme replacement therapy. It is a recombinant human α–Galactosidase–A enzyme expressed in a plant-cell culture designed to provide a long half-life.

Also Read: Protalix Clocks 40% Decline In Q1 Revenues Reflecting Lower Sales To Brazil.

Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa) in the European Union for Fabry disease.

Elfabrio competes with Sanofi SA's SNY Fabrazyme and Amicus Therapeutics Inc's FOLD Galafold in treating Fabry disease.

Almost two years back, the companies received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‑102) for Fabry disease.

Price Action: PLX shares are up 1.54% at $2.97 on the last check Wednesday.