Posted by Michael Wonder on 04 Nov 2025
Chiesi Global Rare Diseases and Protalix BioTherapeutics seek re-examination from the EMA for the negative opinion for Elfabrio (pegunigalsidase alfa) alternative dosing regimen of every four weeks in the EU
3 November 2025 - Every two weeks remains approved as a dosing regimen of Elfabrio in the EU.
Chiesi Global Rare Diseases and Protalix BioTherapeutics have requested a re-examination of the recent negative opinion issued by the CHMP of the EMA regarding the proposed dosing regimen of 2 mg/kg body weight infused every 4 weeks for Elfabrio (pegunigalsidase alfa).
