STOCKHOLM - BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has received approval for Leqembi (lecanemab-irmb) in China for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's dementia. This makes China the third country to approve the drug, following the United States in July 2023 and Japan in September 2023.
Leqembi targets amyloid-beta (Aβ) aggregates, which are associated with the disruption of brain function in Alzheimer's patients. The drug has been shown to reduce the rate of disease progression and slow cognitive and functional decline. The approval in China is based on positive results from the global Phase 3 Clarity AD study, which met its primary and key secondary endpoints.
Eisai is preparing for the launch of Leqembi in China in the third quarter of 2024, with an estimated 17 million patients currently affected by MCI or mild dementia due to Alzheimer's disease in the country. The company plans to distribute the product, engage in awareness activities, and improve diagnostic environments, including the use of blood-based biomarkers.
BioArctic, which has been collaborating with Eisai on the development and commercialization of Leqembi, will not incur development costs and is entitled to receive payments for regulatory approvals, sales milestones, and royalties on global sales. The company also retains the right to commercialize the drug in the Nordic region, pending European approval.
The information provided is based on a press release statement from BioArctic AB.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.