Eisai and Biogen Announce Approval of LEQEMBI® (Lecanemab) for Alzheimer’s Disease Treatment in Hong Kong

11 July 2024 | Thursday | News


 Eisai Co., Ltd. and Biogen Inc. are pleased to announce that the Department of Health in Hong Kong has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI® (generic name: lecanemab) for the treatment of Alzheimer’s disease (AD)
Image Source : Public Domain

Image Source : Public Domain

LEQEMBI is now available for patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early AD, the population in which treatment was initiated in clinical trials.

LEQEMBI selectively binds to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques. This binding reduces both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment demonstrated to reduce the rate of disease progression and slow cognitive and functional decline through this mechanism. Hong Kong joins the U.S., Japan, China, and South Korea in approving LEQEMBI.

The approval in Hong Kong is based on the results of the large global Phase 3 Clarity AD study, where LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 years and older live with dementia, increasing to 32% in those aged 85 years and older. Of those with dementia, 73.5% are reported to have Alzheimer's disease.

Eisai is leading the development and regulatory submissions for lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai will distribute LEQEMBI in Hong Kong.

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