LEQEMBI (Lecanemab) Gains Approval in South Korea for Alzheimer’s Disease Treatment
EiSai and Biogen have announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved the use of the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, LEQEMBI (lecanemab), for adult patients experiencing mild cognitive impairment due to Alzheimer’s disease (AD) or those in the early stages of the disease.
LEQEMBI targets soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are crucial components of Aβ plaques in Alzheimer's disease. By doing so, it reduces both protofibrils and plaques in the brain. This treatment is unique as it is the first to be approved that slows both cognitive and functional decline by reducing the rate of disease progression. South Korea joins the United States, Japan, and China in approving this medication.
In 2021, South Korea had approximately 900,000 dementia patients, with one in ten people over 65 affected by the condition. Additionally, one in five individuals suffer from mild cognitive impairment (MCI). The estimated annual cost for nursing care and medical expenses per dementia patient is around 21.1 million KRW, which increases to 33.1 million KRW for those with severe dementia.
Eisai leads the global development and regulatory submissions for LEQEMBI, with Eisai and Biogen sharing responsibilities for commercialization and promotion. In South Korea, Eisai Korea Inc. will handle distribution and provide related information. Eisai remains dedicated to collaborating with healthcare professionals and other stakeholders to ensure early diagnosis and treatment of Alzheimer’s disease.
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