
The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the U.S. Food and Drug Administration (FDA) has unanimously voted in favour of the clinical benefit of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for the treatment of Alzheimer's disease (AD). LEQEMBI received approval under the FDA's accelerated approval pathway based on Eisai's Phase 3 Clarity AD clinical trial data. The trial met its primary endpoint, demonstrating a significant slowing of cognitive and functional decline compared to placebo over 18 months. Treatment effects were also observed for secondary endpoints measuring cognition and functional changes. The most common adverse events in the LEQEMBI group included infusion reactions, ARIA-H (cerebral microhemorrhages, microhemorrhages, and superficial siderosis), ARIA-E (oedema/effusion), headache, and falls. Infusion reactions were mostly mild-to-moderate and occurred primarily after the first dose. Eisai is leading the global development and regulatory submissions of lecanemab.
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