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How Could EMA's Elfabrio Decision Reshape Protalix BioTherapeutics' (PLX) Rare Disease Strategy?
Earlier in October 2025, Protalix BioTherapeutics and Chiesi Group received a negative opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding Elfabrio’s proposed less-frequent dosing regimen for Fabry disease, as the data was considered insufficient to demonstrate similar efficacy to the currently approved schedule.
This regulatory decision highlights ongoing challenges in achieving flexibility for rare disease treatments, with...