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.S., the appr ...