Chiesi Group's Unit And Protalix BioTherapeutics Say CHMP Of EMA Issues Positive Opinion Recommending Approval Of 2mg/Kg E4W Dosing Regimen For Elfabrio In Fabry Disease Adult Patients Stable With ERT Treatment

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.S., the approved dosing regimen remains 1 mg/kg every 2 weeks. Please consult with your healthcare provider

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: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.