Protalix and Chiesi request re-examination of negative EMA opinion on Elfabrio E4W dosing regimen

Protalix BioTherapeutics, Inc.

CHMP issued negative opinion on Elfabrio 2 mg/kg every-4-weeks dosing regimen; re-examination requested.
Existing EU marketing authorization for every-2-weeks regimen remains in effect pending outcome.
Approved E2W dosing regimen unchanged; companies committed to addressing Fabry community needs.
Re-examination process underway; timeline for final EC decision not disclosed.

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