BRIEF—Alzheimer drug Leqembi now approved in China

Japan’s Eisai and US biotech Biogen announced that their humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.

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

Eisai estimates that there will be 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population.

Eisai will distribute the product in China and will conduct information provision activities through specialized medical representatives.

Leqembi was first approved in January under the Accelerated Approval pathway in January 2023, and this was converted to traditional approval in July.

It also gained approval in September in Japan, where it was launched in December, and is still under revue in the European Union and the UK.

Eisai has forecast $7 billion in worldwide sales of the drug by 2030.