China is the Third Country to Approve LEQEMBI Following the United States and Japan
TOKYO and CAMBRIDGE, Mass., Jan 10, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that humanized anti- soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI" (generic name: 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.
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.
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. Moving forward, Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment, including blood-based biomarkers. In addition, by utilizing online health platform for the elderly "Yin Fa Tong"**, which is already being accessed by a certain number of users and helping provide treatments, Eisai is providing a one-stop service that promotes early consultation by referring patients to medical specialists and follow-up after treatment. In addition, Eisai will work to improve access environments including the development of insurance programs for AD in collaboration with insurance companies. Through these efforts, Eisai will accelerate the construction of a simple patient journey in China.
* Protofibrils are large Aß aggregated soluble species of 75-5000 Kd.1,2,3.
** An online business of Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture company with JD Health.
For more information, visit https://www.eisai.com/news/2024/news202403.html.
MEDIA CONTACTS
Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120
Biogen Inc.
Jack Cox
+ 1-781-464-3260
public.affairs@biogen.com
Source: Eisai
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