Eisai and Biogen Announce FDA Acceptance of LEQEMBI® Application for Early Alzheimer’s Disease Treatment

发布时间： 2025-01-24 阅读：104次

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January 13, 2025 -- Eisai and Biogen have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for LEQEMBI® (lecanemab-irmb) subcutaneous autoinjector (SC-AI) for maintenance dosing.

Alzheimer’s disease is a progressive neurological condition driven by a toxic process that persists before and after amyloid plaque deposition in the brain.

LEQEMBI has been shown to work in two ways: clearing toxic protofibrils and rapidly reducing plaque levels. Long-term data presented at the Alzheimer’s Association International Conference in 2024 suggest that early and continuous use of LEQEMBI could prolong therapeutic benefits, even after plaque has been cleared.

This treatment is intended for individuals with early-stage Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) or mild dementia.

LEQEMBI has already been approved in multiple countries, including the United States, Japan, China, South Korea, and the United Kingdom.

It recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending approval in the European Union.