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Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa)

Protalix BioTherapeutics, Inc. (DE) (PLX) 
Company Research Source: GlobeNewswire
This press release is intended for US audiences for transparency relative to global news for the Fabry community. This dosing regimen for Elfabrio is not approved in the US. In the US, the FDA-approved dosing regimen remains 1mg/kg every 2 weeks. Please see Important Safety Information below and the Full Prescribing Information, including Boxed Warning. European Commission approved dosing regimen reduces the burden for eligible patients, their families, and the broader healthcare system by extending infusion interval frequency from every-two-weeks to every-four-weeks for those stable with an enzyme replacement therapy (ERT) With this decision, announced ahead of Fabry Disease Awareness Month in April, Chiesi Global Rare Diseases will work with countries across the EU to support broader access to this additional dosing schedule for the adult Fabry community PARMA, Italy and CARMIEL, Israel, March 09, 2026 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chie Show less Read more
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