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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) ▼
Approved dosing regimen reduces the burden for eligible patients, their families, and the broader healthcare system by extending infusion interval 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
About this update from Protalix Biotherapeutics, Inc. (de)
[{"type":"image","alt":"Chiesi Global Rare Diseases","displaySize":"","headline":null,"caption":"Chiesi Global Rare Diseases","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":138,"url":"https://media.zenfs.com/en/globenewswire.com/9ef765237cc81158e8a73228d21a22b4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Y0m00zdCu20g_4gFOTuo2w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE5MztjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/9ef765237cc81158e8a73228d21a22b4","width":300,"height":138}},"lazy":false},{"type":"text","content":"Approved dosing regimen reduces the burden for eligible patients, their families, and the broader healthcare system by extending infusion interval from every-two-weeks to every-four-weeks for those stable with an enzyme replacement therapy (ERT)","length":245,"tagName":"p"},{"type":"text","content":"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","length":236,"tagName":"p"},{"type":"text","content":"PARMA, Italy and CARMIEL, Israel, March 09, 2026 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today announced that the European Commission (EC) has approved the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in adults living with Fabry disease who are stable with an ERT. The EC decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the additional dosing regimen.","length":850,"tagName":"p"},{"type":"text","content":"“The European Commission approval for 2mg/kg body weight E4W dosing regimen for pegunigalsidase alfa represents a meaningful advancement for adults living with Fabry disease and their families,” said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. “Because Fabry disease requires lifelong treatment, th...