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Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of 2mg/kg Body Weight Every-Four-Weeks for Elfabrio® (pegunigalsidase alfa) ▼ in the EU
Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March 2026 If approved by the EC, this dosing regimen would reduce the burden to eligible adult patients, their families and the broader healthcare system due to the current requirement to visit infusion centres or have home infusions every-2-weeks for treatment PARMA, Italy and CARMIEL, Israel, Jan. 30, 2
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":"Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March 2026","length":203,"tagName":"p"},{"type":"text","content":"If approved by the EC, this dosing regimen would reduce the burden to eligible adult patients, their families and the broader healthcare system due to the current requirement to visit infusion centres or have home infusions every-2-weeks for treatment","length":251,"tagName":"p"},{"type":"text","content":"PARMA, Italy and CARMIEL, Israel, Jan. 30, 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 an update on pegunigalsidase alfa. The Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an enzyme replacement therapy. This positive opinion follows the CHMP’s re-examination of the company’s application for the additional dosing regimen.","length":928,"tagName":"p"},{"type":"text","content":"“It is our privilege to provide the adult Fabry community with an alternative dosing option, and we are pleased that the CHMP positive opinion supporting a 2mg/kg body weight E4W dosing regimen for pegunigalsidase alfa brings us one step forward to reducing the treatment bu...