FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review LEQEMBI received accelerated approval from the … Read more