South Korea Approves Lecanemab for Alzheimer's Treatment

On May 27, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) gave the green light to the humanized anti-soluble amyloid-β (Aβ) monoclonal antibody known as LEQEMBI® (lecanemab) for treating Alzheimer's disease (AD) or early AD characterized by mild cognitive impairment. This marks a significant advancement as LEQEMBI is the first and only treatment approved through this mechanism that can decelerate disease progression and mitigate cognitive and functional decline. South Korea joins the United States, Japan, and China as the fourth nation to approve lecanemab.

In terms of numbers, South Korea had about 900,000 dementia sufferers as of 2021, with dementia affecting one in ten individuals aged 65 and older, and one in five experiencing mild cognitive impairment (MCI). The annual care and medical expenses for a dementia patient in South Korea average around 21.1 million won, with costs rising to 33.1 million won for those with severe dementia.

The development and commercialization of lecanemab are spearheaded by Eisai and Biogen, with Eisai holding the ultimate decision-making authority. Eisai's South Korean branch will oversee the distribution and promotion of the medication in the local market. Eisai is dedicated to partnering with healthcare professionals and other stakeholders to facilitate early diagnosis and treatment of Alzheimer's disease.

The South Korean approval of lecanemab is a major milestone in the ongoing battle against Alzheimer's disease in the country. It provides a new treatment avenue that could significantly improve the lives of patients and their families by offering a way to slow the progression of this debilitating neurodegenerative disorder.