The South Korean Ministry of Food and Drug Safety (MFDS) has granted approval for Eisai and Biogen’s LEQEMBI
The South Korean Ministry of Food and Drug Safety (MFDS) has granted approval for Eisai and Biogen’s LEQEMBI (lecanemab) for use in adults with mild cognitive impairment due to mild Alzheimer's disease (AD). This marks South Korea as the fourth nation to approve the treatment after the US, China and Japan.
LEQEMBI is a humanised anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody that targets both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils) found in AD. Lecanemab is developed through a research alliance between Eisai and BioArctic. It is claimed to be the first and only treatment demonstrated to lower disease progression and slow down cognitive and functional decline.
Eisai is overseeing the development and regulatory submissions for LEQEMBI globally, with joint commercialisation and promotion of the product alongside Biogen. Eisai retains the final decision-making authority. In South Korea, Eisai Korea will manage the distribution and information provision activities related to LEQEMBI.
Lecanemab is approved in the US to treat AD in patients with mild cognitive impairment (MCI) or mild dementia stage of the disease. The FDA's approval of LEQEMBI was based on the data from Phase III Clarity AD clinical trial. The trial met its primary endpoint and all key secondary endpoints with statistically significant results.
Eisai also filed applications for lecanemab's approval in 13 countries and regions, including the European Union. In the US, a supplemental biologics license application (sBLA) for intravenous maintenance dosing was submitted in March this year. Additionally, the rolling submission of a biologics license application (BLA) for a subcutaneous injection formulation began recently under fast track status, aiming to enhance patient convenience.
May 29, 2024
