EU Panel Backs Expanded Dosing of Protalix's Fabry Disease Drug, Elfabrio

Protalix Biotherapeutics has received a positive opinion from the European Medicines Agency's human medicines committee for an expanded dosing regimen of Elfabrio, its treatment for Fabry disease. The committee recommended approval of a 2 mg/kg every-four-weeks dosing schedule for adult patients stable on enzyme replacement therapy. Approval by the European Commission would trigger a $25 million regulatory milestone payment to Protalix. Shares of Protalix gained 8.7% on the news.