EMA Re-Examines Elfabrio Dosing Regimen, Protalix and Chiesi Seek Approval
ByAinvest
Tuesday, Nov 4, 2025 8:59 am ET1min read
PLX--
Protalix Biotherapeutics and Chiesi Global Rare Diseases have requested a re-examination of the European Medicines Agency's negative opinion on a new dosing regimen for Elfabrio, a treatment for Fabry disease. The companies remain committed to working with the EMA and addressing the needs of the Fabry community. The existing marketing authorization for Elfabrio remains valid during the re-examination process.
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