Lecanemab Approved in South Korea for the Treatment of Alzheimer's Disease

On May 27th, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) approved the humanized anti-soluble amyloid-β (Aβ) monoclonal antibody LEQEMBI® (lecanemab) for the treatment of Alzheimer's disease (AD) or mild AD (early AD) with mild cognitive impairment.

LEQEMBI is the first and only therapy approved through this mechanism that can slow disease progression and delay cognitive and functional decline. South Korea is the fourth country to approve lecanemab, following the United States, Japan, and China.

According to statistics, as of 2021, South Korea had approximately 900,000 dementia patients, with one in ten people aged 65 and above having dementia and one in five having mild cognitive impairment (MCI). The average annual care and medical costs for a dementia patient in South Korea are around 21.1 million won, and for a severe dementia patient, the costs can reach 33.1 million won.

Eisai and Biogen are co-developing and co-commercializing lecanemab globally, with Eisai having final decision-making authority. Eisai's South Korean subsidiary will be responsible for the distribution and promotion of the product in the country. Eisai is committed to collaborating with healthcare professionals and other stakeholders to enable early diagnosis and treatment of Alzheimer's disease.

The approval of lecanemab in South Korea represents a significant milestone in the ongoing efforts to address the growing burden of Alzheimer's disease in the country. This treatment option has the potential to make a meaningful difference in the lives of patients and their families, offering hope for slowing the progression of this devastating neurodegenerative condition.