Lecanemab-irmb (Leqembi – Eisai/Biogen), the IV amyloid-directed monoclonal antibody that received accelerated approval from the FDA in January 2023 for treatment of early Alzheimer’s disease, has now received full approval from the FDA based on a trial showing that it slowed cognitive and functional decline in patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease dementia and confirmed presence of brain amyloid.

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