PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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

Vandana Singh

Wed, May 10, 2023 at 11:16 PM GMT+3

https://finance.yahoo.com/news/fabry-disease-treatment-showdown-protalix-201601855.html

The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's (NASDAQ: 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 a–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 (NASDAQ: SNY) Fabrazyme and Amicus Therapeutics Inc's (NASDAQ: 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.