Protalix, Chiesi Global: CHMP issues positive opinion for Elfabrio dosing

Chiesi Global Rare Diseases and Protalix (PLX) BioTherapeutics announced an update on Elfabrio. The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks dosing regimen for Elfabrio in Fabry disease adult patients stable with an ERT treatment. This positive opinion follows the CHMP’s re-examination of the company’s application for the additional dosing regimen.