On 9 January, Eisai and Biogen announced that their anti-amyloid drug, lecanemab, has been approved in China. Lecanemab is an antibody that targets plaques of amyloid-beta proteins, which accumulate in the brain during the development of AD. The drug, which is marketed under the brand name Leqembi™ in the US, received regulatory approval from the Japanese authorities last September, following traditional approval by the US Food and Drug Administration in July. Approval by the Chinese medicines authority was based on the CLARITY-AD study, a Phase 3 clinical trial that showed a substantial reduction in brain amyloid, as well as a 27% slowing in clinical decline after 18 months of lecanemab treatment. Similar to Japan and the US, lecanemab is approved for the treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease. In their press release, the companies explained that they are preparing to launch lecanemab in China within the second quarter of Eisai’s upcoming financial year (July-September 2024).
Lecanemab approved for the treatment of early Alzheimer’s disease in China
09/01/2024