Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases announced that the European Commission approved the 2 mg/kg every-4-weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults with Fabry disease stable on ERT. Protalix is entitled to a $25 million regulatory milestone payment from Chiesi.
Key takeaways
European Commission approved 2mg/kg every-4-weeks dosing for Elfabrio on March 9, 2026
Approval for adults with Fabry disease stable on enzyme replacement therapy
Follows positive CHMP opinion recommending the additional regimen
Protalix entitled to $25 million milestone payment from Chiesi
US FDA dosing remains 1mg/kg every 2 weeks
Informed by BRIGHT study (PB-102-F50) and extension CLI-06657AA1-03