South Korea’s MFDS Approves LEQEMBI for Alzheimer’s

The South Korean Ministry of Food and Drug Safety (MFDS) has recently approved LEQEMBI (lecanemab), a treatment developed by Eisai and Biogen, for adults with mild cognitive impairment or mild Alzheimer's disease (AD). This makes South Korea the fourth country to authorize the use of LEQEMBI, joining the United States, China, and Japan.

LEQEMBI is a humanized monoclonal antibody that targets amyloid-beta (Aβ) aggregates, which are associated with Alzheimer's disease. Specifically, it focuses on both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils). This dual-action mechanism is designed to not only reduce the progression of the disease but also slow down the cognitive and functional deterioration seen in patients.

The development of lecanemab is the result of a collaborative effort between Eisai and BioArctic. It is touted as the first and only treatment that has been shown to both lower disease progression and mitigate cognitive and functional decline.

Eisai is handling the development and regulatory submissions for LEQEMBI on a global scale. The company is also responsible for the joint commercialization and promotion of the treatment with Biogen. However, Eisai retains the ultimate decision-making authority concerning the product. In South Korea, distribution and information provision activities related to LEQEMBI will be managed by Eisai Korea.

In the United States, LEQEMBI has been approved for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. The approval by the FDA was based on data from the Phase III Clarity AD clinical trial. This trial achieved its primary endpoint and all key secondary endpoints with statistically significant results, affirming the treatment's efficacy.

Beyond South Korea and the United States, Eisai has also submitted applications for lecanemab's approval in 13 other countries and regions, including the European Union. In the United States, a supplemental biologics license application (sBLA) for intravenous maintenance dosing was submitted earlier this year in March. Additionally, a rolling submission of a biologics license application (BLA) for a subcutaneous injection formulation is underway. This formulation aims to enhance patient convenience and is being fast-tracked.

The approval of LEQEMBI in multiple countries represents a significant milestone in the fight against Alzheimer’s disease. It offers a new avenue for treatment for patients in the early stages of the disease, potentially improving their quality of life by slowing down the progression of symptoms. With ongoing regulatory submissions and the promise of more convenient dosing options, LEQEMBI could become a widely accessible treatment for Alzheimer’s disease in the near future.