Posted by Michael Wonder on 10 Mar 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission approval of additional dosing regimen of every four weeks for Elfabrio (pegunigalsidase alfa)
9 March 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced that the European Commission has approved the 2 mg/kg every 4 weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults living with Fabry disease who are stable with enzyme replacement therapy.
The European Commission decision follows the positive opinion from the CHMP of the EMA recommending the additional dosing regimen.
