Protalix BioTherapeutics Inc. and Chiesi Global Rare Diseases announced that the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$ has issued a positive opinion recommending the approval of a new dosing regimen for Elfabrio® (pegunigalsidase alfa) in the European Union. The recommended regimen is 2 mg/kg every four weeks for adult Fabry disease patients who are stable on enzyme replacement therapy. The CHMP's opinion follows a re-examination of the application and will be reviewed by the European Commission, with a decision expected by March 2026. If approved, this regimen would offer an alternative to the current treatment schedule, which requires infusions every two weeks. This dosing regimen is not currently approved in the United States, where the approved regimen remains 1 mg/kg every two weeks.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Protalix BioTherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9646172) on January 30, 2026, and is solely responsible for the information contained therein.