REGULATORY INTELLIGENCE·EMA Action
Acadia Pharmaceuticals' Daybu (Trofinetide) Secures CHMP Positive Opinion for Rett Syndrome, Opening 30-State EEA Market
Acadia Pharmaceuticals' Daybu (Trofinetide) has received a positive opinion from the CHMP for Rett syndrome in patients aged five and older. This critical regulatory milestone paves the way for market authorization across 30 EEA states, significantly expanding access to this rare disease therapy. Procurement, regulatory, and supply chain teams must now prepare for imminent European market entry and distribution logistics.
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