Alzheimer’s Drug LEQEMBI Approved for Treatment in Hong Kong

On July 11, Eisai and Biogen received approval for their Alzheimer’s drug,  LEQEMBI (lecanemab) from the Department of Health in Hong Kong. LEQEMBI is a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody drug and will now be available as a treatment option for patients with mild cognitive impairment (MCI) or mild dementia stage (denoted as early AD).

LEQEMBI’s Phase 3 Clarity Study Validates Efficacy in Slowing Alzheimer’s Progression 

Hong Kong cleared LEQEMBI based on results from the extensive global Phase 3 Clarity AD study. This research showed that LEQEMBI met all primary and secondary endpoints with statistically significant outcomes. In Hong Kong, dementia affects 9.3% of individuals aged 70 and older, rising to 32% for those aged 85 and older. Among people with dementia, 73.5% have been diagnosed with Alzheimer’s disease.

Here, the study’s success highlights LEQEMBI’s potential in addressing a prevalent condition within the area. Specifically, the drug was able to slow cognitive and functional decline in patients. LEQEMBI decreased brain amyloid plaques, a crucial indicator of AD, by 30%. Furthermore, patients also demonstrated a 20% improvement in daily living activities, followed by a 25% improvement in cognitive assessments. These encouraging outcomes confirm the drug’s capacity to both prevent Alzheimer’s progression as well as improve overall QoL (quality of life).

LEQEMBI Targets Toxic Aβ Protofibrils and Stable Fibrils

LEQEMBI exhibits selectivity in binding to both soluble Aβ aggregates, referred to as protofibrils, and insoluble Aβ aggregates, referred to as fibrils. Protofibrils are considered the most toxic form of Aβ, causing brain damage linked to AD. These oligomeric Aβ aggregates cause neuronal damage and disrupt cell-to-cell signal transmission, which greatly contributes to cognitive loss in the brain. Alternatively, the aggregation of Aβ peptides forms fibrils. These will accumulate and form dense, thread-like structures, which ultimately combine further to become amyloid plaques. Fibrils are also a defining characteristic of Alzheimer’s patients; however, they are considered less toxic than protofibrils since they are more stable and less likely to cause immediate neuronal damage. The accumulation of fibrils over time may result in cognitive impairment and neurodegeneration.

Hong Kong Approves Eisai and Biogen’s LEQEMBI, Joining Five Other Regions 

Eisai Co., Ltd. has a reputation for its expertise in neurology and oncology. They specialize in the development and commercialization of pharmaceutical products for neurological disorders. Biogen Inc. focuses on the discovery and development of innovative therapies for neurological and neurodegenerative diseases. With the approval of the Department of Health in Hong Kong, both companies will collaboratively lead the development and regulatory submissions for LEQEMBI. Eisai will be responsible for overseeing the distribution of the drug in the area and ensuring efficient delivery to healthcare providers and patients. In contrast, Biogen will concentrate on the product’s co-commercialization and co-promotion. 

The approval of LEQEMBI in Hong Kong marks a significant milestone in AD treatment in the region. The drug is the first approved treatment to lower disease progression rates and delay cognitive and functional decline. Hong Kong now joins the U.S., Japan, China, South Korea, and Israel in approving LEQEMBI for AD treatment.

Dementia affects a large percentage of Hong Kong’s elderly population. This approval addresses one of the region’s most pressing healthcare needs. Eisai and Biogen’s collaboration ensures that patients will have access to effective treatments. This partnership enhances the commitment to improve healthcare outcomes and tackle neurodegenerative disease challenges in the elderly population.

Author

Denisse Sandoval

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