EC approves Elfabrio every-4-weeks dosing; Protalix gets $25M milestone

Protalix BioTherapeutics, Inc.

European Commission approved 2 mg/kg every-4-weeks regimen for Elfabrio in stable adult Fabry patients.
Decision follows positive CHMP opinion; dosing reduces infusion frequency from every-2-weeks.
Protalix entitled to a $25 million regulatory milestone payment from Chiesi upon EC approval.
US FDA-approved dosing remains 1 mg/kg every 2 weeks; not affected by EU decision.
BRIGHT study (PB-102-F50) and extension study supported the alternative dosing regimen.

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