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Protalix BioTherapeutics, Chiesi Global Get FDA Approval for Elfabrio

By Chris Wack Protalix BioTherapeutics and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, said Wednesday that the U.S. Food and Drug Administration has approved Elfabrio. | May 10, 2023

FDA Approves Pegunigalsidase Alfa for Adults with Fabry Disease

The FDA approval comes with supporting data showing the ERT's non-inferiority to agalsidase beta in controlled eGFR decline.

Rare Disease Drug Approval Brings New Competition to Meds from Sanofi, Takeda

A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.

FDA approves Elfabrio as treatment for Fabry disease

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

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