Leqembi® Receives Approval for the Treatment of Alzheimer's Disease in China
Wednesday, January 10, 2024
Eisai, in collaboration with BioArctic AB, announced today that Leqembi® (lecanemab-irmb) has received approval in China for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. China is the third country to grant marketing approval, following the United States in July 2023 and Japan in September 2023. Eisai is preparing for the Chinese launch in the third quarter of 2024.
Leqembi is a humanized monoclonal antibody that selectively binds to both soluble (protofibrils) and insoluble aggregates of amyloid-beta (Aβ) in the brain. It is the first and only approved treatment shown to reduce the rate of disease progression, slowing cognitive and functional decline. The approval in China is based on the positive results from the global Phase 3 Clarity AD study, where Leqembi met primary and key secondary endpoints with statistically significant outcomes.
Eisai estimates there are currently 17 million patients with MCI or mild dementia due to AD in China, a number expected to increase with the aging population. The company plans to distribute Leqembi in China and engage in awareness campaigns, utilizing omnichannel systems and collaborating with specialists to improve the diagnostic environment, including the use of blood-based biomarkers. Eisai also aims to enhance access environments, including insurance programs for AD, to simplify the patient journey.
BioArctic's long-term collaboration with Eisai involves development and commercialization for Leqembi. While Eisai handles clinical development, market approval applications, and commercialization, BioArctic is entitled to payments for certain regulatory approvals, sales milestones, and royalties on global sales. BioArctic also has the right to commercialize lecanemab in the Nordic region, pending European approval.
Leqembi's indication for use is the treatment of MCI due to Alzheimer's disease and mild AD dementia, with a recommended dosage of 10mg/kg infused intravenously once every two weeks. The drug is available in vials containing 200mg (2mL) and 500mg (5mL) of the active ingredient lecanemab.
Leqembi is a significant outcome of the strategic research alliance between BioArctic and Eisai, offering a disease-modifying treatment for Alzheimer's disease. The approval in China further expands the global availability of this groundbreaking therapy.
Source: prnewswire.com
