Eisai submits sBLA for monthly Leqembi® dosing in early Alzheimer's disease to the FDA.
Eisai has submitted a supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (Leqembi®) intravenous maintenance dosing to the US Food and Drug Administration (FDA) for the treatment of early Alzheimer's disease. Leqembi is indicated for Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease. The sBLA is based on data from the Phase 2 study and its open-label extension, as well as Clarity AD study and its OLE study.
April 01, 2024
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