Saturday, June 22, 2024

Alzheimer’s Disease Treatment: LEQEMBI® (Lecanemab) Approved in South Korea

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Alzheimer’s disease treatment has taken a significant step forward with the approval of LEQEMBI® (lecanemab) by the Ministry of Food and Drug Safety (MFDS) in South Korea. Eisai Co., Ltd., headquartered in Tokyo and led by CEO Haruo Naito, alongside Biogen Inc., headquartered in Cambridge, Massachusetts, and led by CEO Christopher A. Viehbacher, have announced this milestone. This humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody is now approved for adult patients experiencing mild cognitive impairment (MCI) due to AD or mild AD (early AD).

LEQEMBI® works by selectively binding to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), the major components of Aβ plaques in AD. By targeting these aggregates, LEQEMBI® effectively reduces both Aβ protofibrils and Aβ plaques in the brain. It is the first and only treatment approved that has been shown to reduce the rate of disease progression and slow cognitive and functional decline through this mechanism. With South Korea joining the list of approving countries, which includes the U.S., Japan, and China, this marks a significant milestone in the global fight against Alzheimer’s.

In South Korea, the prevalence of dementia is substantial, with approximately 900,000 patients in 2021. Among those aged 65 and older, one in ten suffer from dementia, and one in five from mild cognitive impairment (MCI). The economic impact is significant, with the average annual nursing care and medical costs per dementia patient estimated at 21.1 million KRW, escalating to 33.1 million KRW for patients with severe dementia.

Eisai leads the development and regulatory submissions for LEQEMBI® globally, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai holds the final decision-making authority. In South Korea, Eisai Korea Inc. will handle the distribution and information provision activities for LEQEMBI®. Eisai remains dedicated to collaborating with healthcare professionals and other stakeholders to promote the early diagnosis and treatment of AD.

LEQEMBI®’s efficacy lies in its ability to target and reduce protofibrils, which are believed to be the most toxic form of Aβ and a primary contributor to the cognitive decline seen in Alzheimer’s. Protofibrils cause significant brain injury, impacting cognitive function by increasing the development of insoluble Aβ plaques, directly damaging brain cell membranes, and disrupting the connections that transmit signals between nerve cells. By reducing protofibrils, LEQEMBI® helps prevent the progression of AD, thus mitigating the damage to neurons and subsequent cognitive dysfunction.

Alzheimer's Disease

Eisai and Biogen’s Collaborative Efforts in Developing and Commercializing LEQEMBI®

Eisai and Biogen’s joint efforts in the development and commercialization of LEQEMBI® demonstrate a robust partnership aimed at addressing one of the most challenging and debilitating conditions affecting the aging population. Their collaboration ensures a comprehensive approach to treatment, from early-stage research and development to patient access and support.

The approval of LEQEMBI® in South Korea represents a significant advancement for patients with Alzheimer’s disease and their families. It provides a new therapeutic option that addresses the underlying pathology of AD, offering hope for improved management and better quality of life for those affected. The availability of LEQEMBI® also underscores the importance of early diagnosis and intervention in managing AD, potentially altering the disease course and reducing the long-term burden on patients and the healthcare system.

In conclusion, the approval of LEQEMBI® (lecanemab) in South Korea marks a pivotal step forward in the treatment of Alzheimer’s disease. With its unique mechanism targeting protofibrils and Aβ plaques, LEQEMBI® offers a promising solution to slow the progression of this debilitating condition. Eisai and Biogen’s commitment to advancing AD treatment through innovative therapies like LEQEMBI® is a testament to their dedication to improving patient outcomes and transforming the landscape of Alzheimer’s care. As more countries recognize and approve this groundbreaking treatment, the global fight against Alzheimer’s disease gains momentum, bringing hope to millions of patients and their families worldwide.

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Resource: Biogen, May 26, 2024

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