NMPA (China) approves Leqembi as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease

Preparations for launch within the second quarter of Eisai’s FY 2024 (July 1 – September 30, 2024) are underway.

Leqembi selectively binds to soluble Abeta aggregates (protofibrils), as well as insoluble Abeta aggregates (fibrils) which are a major component of Abeta plaques, thereby reducing both Abeta protofibrils and Abeta plaques in the brain. Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.

Leqembi’s approval in China is based on the large global Phase III Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal (previously cited).