Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, the Company's development and commercialization partner, issued a release announcing that the European Commission (EC) has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of adult patients with Fabry disease. It has been studied in both ERT-na ve and ERT-experienced patients, including a head-to-head trial that met its primary endpoint, with PRX-102 demonstrating non-inferior efficacy to agalsidase beta in controlling kidney disease as evaluated by the estimated glomerular filtration rate (eGFR) decline. Pegunigalsidase alfa, an investigational new drug product, is currently not approved by the U.S. Food and Drug Administration (FDA).

The effectiveness and safety of pegunigalsidase alf is under review, but has not yet been approved, by the FDA. Prior to FDA review and approval, no conclusions can be drawn on pegunigalsidase Alfa's efficacy and safety profile. When seeking expanded access, treating physicians should consider all possible risks of treatment with pegunigalsidaseAlfa.

The ultimate consequences of Gb deposition range from episodes of pain and impaired peripheral sensation to end-organ failure. PRX-102 (pe Gunigalsidase alfa). PRX-102 (peganigalsidase alfa), is a PEGylated enzyme replacement therapy (ERT) to treat Fabry disease that is now approved by the European Medicines Agency (EMA) and is under evaluation by the FDA.

PRX-102 is a plant cell culture-expressed, and chemically modified stabilized recombinant version of, the -Galactosidase-A enzyme.