Protalix BioTherapeutics and partner secure EU approval for new Fabry disease dosing regimen

Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) announced that the European Commission has approved a new dosing regimen for pegunigalsidase alfa for adults with Fabry disease who are stable on enzyme replacement therapy (ERT), triggering a $25 million regulatory milestone payment from partner Chiesi Global Rare Diseases. The approval allows eligible patients to receive the therapy at a dose of 2 mg/kg every four weeks, instead of the previous every-two-weeks schedule.