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

Core Insights - The European Commission has approved a new dosing regimen of 2mg/kg every four weeks for Elfabrio (pegunigalsidase alfa) for adults with Fabry disease who are stable on enzyme replacement therapy (ERT), which aims to reduce the treatment burden on patients and families [2][3][4] Company Overview - Chiesi Global Rare Diseases, a unit of the Chiesi Group, focuses on delivering innovative therapies for rare diseases and will collaborate with EU countries to enhance access to the new dosing schedule [2][3] - Protalix BioTherapeutics, a biopharmaceutical company, specializes in developing therapeutics for rare diseases and has partnered with Chiesi for the global development of pegunigalsidase alfa [2][19] Treatment Impact - The new dosing regimen is expected to provide greater flexibility for patients and caregivers, allowing them to spend less time managing treatment and more time on daily life [3][4] - The approval is based on results from the BRIGHT study, which assessed the safety and efficacy of the new dosing schedule over 52 weeks [3][4] Market Context - The approval of the new dosing regimen strengthens the treatment landscape for Fabry disease in the EU, potentially enhancing long-term care options for patients [3][4] - The FDA-approved regimen in the US remains unchanged at 1mg/kg every two weeks, highlighting the differences in regulatory approvals between regions [4]