Health
Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of 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 patients, their families, and the broader healthcare system due to the current requirement to visit infusion centres every two weeks for treatment This dosing regimen for Elfabrio is not approved in the U.S. In the U.
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 patients, their families, and the broader healthcare system due to the current requirement to visit infusion centres every two weeks for treatment","length":225,"tagName":"p"},{"type":"text","content":"This dosing regimen for Elfabrio is not approved in the U.S. In the U.S., the approved dosing regimen remains 1 mg/kg every 2 weeks. Please consult with your healthcare provider","length":177,"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 Elfabrio® (pegunigalsidase alfa). The Committee for Medicinal Products 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 Elfabrio in Fabry disease adult patients stable with an ERT (Enzyme Replacement Therapy) treatment. This positive opinion follows the CHMP’s re-examination of the company’s application for the additional dosing regimen.","length":945,"tagName":"p"},{"type":"text","content":"“It is our privilege to provide the Fabry communit...