Monday, July 15, 2024

Alzheimer’s Disease Treatment Advances as Hong Kong Approves LEQEMBI

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Alzheimer’s disease (AD) treatment has advanced with the announcement from Eisai Co. and Biogen that the Department of Health in Hong Kong has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (lecanemab). This treatment should be initiated in patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early AD, as established in clinical trials.

LEQEMBI is designed to selectively bind to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques. By doing so, LEQEMBI reduces both Aβ protofibrils and plaques in the brain. This mechanism has made LEQEMBI the first approved treatment shown to slow the progression of Alzheimer’s disease and mitigate cognitive and functional decline. Hong Kong joins the U.S., Japan, China, and South Korea as the fifth region to approve this treatment.

The approval in Hong Kong is supported by data from the global Phase 3 Clarity AD study. In this study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. The study demonstrated that LEQEMBI can effectively slow the progression of Alzheimer’s disease, providing hope for patients in the early stages of the condition.

Alzheimer’s Disease Prevalence in Hong Kong Highlights Need for Effective Treatments

In Hong Kong, dementia is a significant concern, with 9.3% of people aged 70 years and older affected by the condition, increasing to 32% for those aged 85 years and older. Among those with dementia, 73.5% were reported to have Alzheimer’s disease. These statistics highlight the urgent need for effective treatments like LEQEMBI in the region.

LEQEMBI’s therapeutic impact is attributed to its ability to target and reduce protofibrils, which are believed to contribute significantly to brain injury in Alzheimer’s disease. Protofibrils are considered the most toxic form of Aβ, playing a primary role in cognitive decline associated with AD. They cause injury to neurons, negatively impacting cognitive function through various mechanisms. This includes not only increasing the development of insoluble Aβ plaques but also directly damaging brain cell membranes and disrupting the connections that transmit signals between nerve cells.

By reducing protofibrils, LEQEMBI aims to prevent the progression of Alzheimer’s disease by mitigating neuronal damage and cognitive dysfunction. This approach sets LEQEMBI apart from other treatments and underscores its potential in managing AD. Eisai leads the development and regulatory submissions for lecanemab worldwide, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai holds the final decision-making authority and will be responsible for distributing LEQEMBI in Hong Kong.

Alzheimer's Disease

Approval of LEQEMBI in Hong Kong Marks Major Advancement in Alzheimer’s Treatment

The approval of LEQEMBI in Hong Kong represents a significant advancement in the treatment of Alzheimer’s disease. For patients and healthcare providers, this new therapy offers a promising option to manage early-stage Alzheimer’s more effectively. By slowing disease progression and reducing cognitive decline, LEQEMBI has the potential to improve the quality of life for patients and reduce the overall burden of AD on families and healthcare systems.

LEQEMBI’s approval in multiple regions, including Hong Kong, underscores its therapeutic potential and the robust clinical data supporting its efficacy. As Eisai and Biogen continue to collaborate on the global commercialization of LEQEMBI, it is expected that more patients worldwide will gain access to this innovative treatment. The ongoing research and development efforts will further elucidate the benefits of reducing Aβ protofibrils and provide deeper insights into the long-term impact of LEQEMBI on Alzheimer’s disease progression.

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In conclusion, the approval of LEQEMBI in Hong Kong marks a pivotal moment in Alzheimer’s disease treatment, offering a new, effective option for early-stage AD patients. With its unique mechanism of action and proven efficacy, LEQEMBI has the potential to transform the management of Alzheimer’s disease and bring hope to millions of patients and their families.

 

Resource: Biogen, July 10, 2024

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