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Leqembi® (lecanemab-irmb) – Accelerated approval converted to traditional approval

July 6, 2023 - The FDA announced the traditional approval of Eisai/Biogen’s Leqembi (lecanemab-irmb), for the treatment of Alzheimer’s disease. Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

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