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of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Protalix BioTherapeutics","sponsor":"Chiesi Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of a Resubmitted Biologics License Application for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 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Gout","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Rheumatology","graph2":"Phase I"},{"orgOrder":0,"company":"Protalix BioTherapeutics","sponsor":"Chiesi Global Rare Diseases","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ISRAEL","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Protalix BioTherapeutics","sponsor":"Chiesi Global Rare Diseases","pharmaFlowCategory":"DU","amount":"Not 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Find Clinical Drug Pipeline Developments & Deals by Protalix BioTherapeutics
Elfabrio (pegunigalsidase alfa-iwxj) is a PEGylated enzyme replacement therapy (ERT) for the treatment of adult patients with Fabry disease. It is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life.
PRX-102 (pegunigalsidase alfa), EC authorized, is a novel PEGylated, covalently crosslinked form of α-galactosidase-A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.
PRX-115 is a PEGylated enzyme expressed via ProCellEx® for intravenous (IV) administration of recombinant Uricase, designed for safe and efficacious treatment of refractory gout
PRX–102 (pegunigalsidase alfa) a novel PEGylated, covalently crosslinked form of α-galactosidase A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.
PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. It is a novel, PEGylated ERT under development for the treatment of Fabry disease.
PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme.
Results from the clinical development programme developed with Protalix BioTherapeutics evaluating pegunigalsidase alfa (PRX-102) an investigational enzyme replacement therapy (ERT), support its potential as a treatment option for adult patients with Fabry disease.
Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties.
PRX–102 is currently being studied in the pivotal Phase III BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX–102 for the proposed treatment of Fabry disease.
Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch.
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