Chiesi, Protalix's PRX-102 secure FDA nod to treat Fabry disease
Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102
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Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102
Pegunigalsidase alfa (Elfabrio) is an intravenously administered enzyme replacement therapy to treat adults with confirmed Fabry disease.
The FDA approval comes with supporting data showing the ERT's non-inferiority to agalsidase beta in controlled eGFR decline.
The FDA has granted approval to Elfabrio, manufactured by Chiesi Global Rare Diseases and Protalix BioTherapeutics Inc. The drug is intended to treat Fabry disease in adults, according to the press release.“This approval is a testament to the dedication of the Protalix and Chiesi teams to deliver this much-needed new therapeutic option to patients in need. The totality of clinical data
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.