Leqembi: China approves Alzheimer's treatment

Eisai and Biogen said on Tuesday that their Alzheimer’s treatment Leqembi had won approval in China, the third country after the United States and Japan.

The two companies are preparing to launch the drug in the second quarter of Eisai’s 2024/25 business year starting in April.

Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer’s patients. It is the first treatment shown to slow progression of the disease for people in the earlier stages of Alzheimer’s.

Japan approved the treatment in September after a standard approval from the U.S. Food and Drug Administration in July.

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(New Window), a peer-reviewed medical journal.