Posted by Michael Wonder on 02 Feb 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU
30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa.
The CHMP of the EMA has issued a positive opinion recommending approval of the 2 mg/kg every 4 weeks dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an enzyme replacement therapy.
This positive opinion follows the CHMP’s re-examination of the company’s application for the additional dosing regimen.
