Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio (pegunigalsidase alfa) (Protalix Press Release) - Mar 9, 2026 - "The EC approval is informed by results from an open-label, switch-over study, BRIGHT (formally PB-102-F50), designed to assess the adverse-event profile, efficacy, and pharmacokinetics (PK) of the alternative dosing regimen of pegunigalsidase alfa 2-mg/kg E4W for 52 weeks, and its ongoing open-label extension study CLI-06657AA1-03 (formerly PB-102-F51)."
EMA approval • Fabry Disease
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