Biogen and Eisai have announced that the Department of Health in Hong Kong has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). This humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody is now available for patients with mild cognitive impairment (MCI) or mild dementia, stages collectively referred to as early AD.
Mechanism of Action
LEQEMBI works by selectively binding to soluble Aβ aggregates (protofibrils) as well as insoluble Aβ aggregates (fibrils), which are key components of Aβ plaques. This binding reduces both Aβ protofibrils and Aβ plaques in the brain. It is the first approved treatment that has been demonstrated to slow the progression of Alzheimer's disease by targeting these specific forms of Aβ, thereby decelerating cognitive and functional decline.
Global and Local Approvals
Hong Kong is the fifth region to approve LEQEMBI, following previous approvals in the United States, Japan, China, and South Korea. The approval in Hong Kong is based on the results from the global Phase 3 Clarity AD study. In this study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant outcomes.
Alzheimer’s Disease in Hong Kong
In Hong Kong, 9.3% of individuals aged 70 and older are living with dementia, with the prevalence rising to 32% among those aged 85 and older. Among these individuals, 73.5% are reported to have Alzheimer’s disease. This high prevalence underscores the urgent need for effective treatments like LEQEMBI in the region.
Development and Commercialization
Eisai is the lead company for the global development and regulatory submissions of lecanemab. Both Eisai and Biogen will co-commercialize and co-promote LEQEMBI, with Eisai holding the final decision-making authority. Eisai will also be responsible for distributing LEQEMBI in Hong Kong.
Significance of Protofibrils
Protofibrils are considered the most toxic form of Aβ, playing a primary role in the cognitive decline associated with Alzheimer’s disease. They cause injury to neurons, leading to cognitive dysfunction and increasing the formation of insoluble Aβ plaques. By reducing protofibrils, LEQEMBI aims to prevent the progression of Alzheimer's disease by mitigating neuronal damage and preserving cognitive function.
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