Eisai Co., Ltd. (CEO: Haruo Naito) and Biogen Inc. (CEO: Christopher A. Viehbacher) announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted approval for LEQEMBI®, a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD).

LEQEMBI is specifically designed to target soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), major components of Aβ plaques in AD patients' brains. By binding to both forms of Aβ aggregates, LEQEMBI effectively reduces their presence in the brain, making it the first approved treatment shown to slow cognitive and functional decline by targeting this mechanism.

South Korea joins the U.S., Japan, and China as the fourth country to grant approval for LEQEMBI. This milestone comes at a critical time, with an estimated 900,000 dementia patients in South Korea in 2021, and one in ten individuals over the age of 65 suffering from dementia, according to statistics. The approval offers hope for the significant portion of the population affected by mild cognitive impairment or early AD, providing a potential avenue for managing the progression of the disease.

Eisai takes the lead in LEQEMBI's development and regulatory submissions globally, with both Eisai and Biogen collaborating on commercialization and promotion efforts. In South Korea, Eisai Korea Inc. will oversee distribution and informational activities, aligning with the companies' shared commitment to advancing early diagnosis and treatment options for AD.

Protofibrils, the target of LEQEMBI, are considered the most toxic form of Aβ and are believed to contribute significantly to the cognitive decline observed in AD patients. By reducing protofibrils, LEQEMBI aims to mitigate neuronal damage and cognitive dysfunction, potentially halting or slowing the progression of AD.

Haruo Naito, CEO of Eisai, expressed his enthusiasm for the approval, stating, "We are pleased to bring LEQEMBI to patients in South Korea, offering hope and tangible progress in the treatment of Alzheimer's disease. This milestone underscores our dedication to addressing the urgent needs of individuals and families affected by this devastating condition."

Christopher A. Viehbacher, CEO of Biogen, echoed this sentiment, emphasizing the importance of collaboration in advancing innovative therapies for AD. "The approval of LEQEMBI in South Korea represents a significant advancement in our collective efforts to combat Alzheimer's disease worldwide. We remain committed to leveraging our combined expertise to make meaningful strides in the fight against this challenging condition."