BRIEF—Alzheimer’s drug Leqembi approved in South Korea

South Korea’s Ministry of Food and Drug Safety (MFDS) has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD), Japan’s Eisai and partner Biogen announced on Monday.

Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

In South Korea, Eisai Korea will distribute the product and conduct information provision activities.

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic.

It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab is approved in the USA, Japan and China.