Pharma Focus Asia

Leqembi Receives Approval for Treating Alzheimer's Disease in Hong Kong

Thursday, July 11, 2024

BioArctic AB (Nasdaq Stockholm: BIOA B) and Eisai have announced that Leqembi® (known as “樂意保®” in Hong Kong), a treatment for Alzheimer’s disease (AD), has been approved by the Department of Health in Hong Kong. This approval marks its fifth global approval, following the US, Japan, China, and South Korea.

The approval in Hong Kong is based on the Phase 3 Clarity AD study, where Leqembi demonstrated efficacy in patients with mild cognitive impairment (MCI) or mild dementia. It selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), major components of Aβ plaques in AD, thereby reducing their presence in the brain. This mechanism makes Leqembi the first approved treatment to slow cognitive and functional decline by targeting disease progression.

Leqembi was originally developed by BioArctic based on the Arctic mutation discovery by Professor Lars Lannfelt. Eisai is leading clinical development, market approvals, and global commercialization. BioArctic will receive payments for regulatory milestones, sales milestones, and a 9% royalty on global sales. BioArctic also retains the right to commercialize Leqembi in the Nordic region, contingent upon European approval.

Lecanemab (Leqembi) is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody approved in several countries based on robust clinical evidence from the Clarity AD study. Eisai has submitted additional applications, including a supplemental Biologics License Application (sBLA) in the US for maintenance dosing to enhance patient convenience. Ongoing studies include AHEAD 3-45 for preclinical AD and Tau NexGen for Dominantly Inherited AD (DIAD), reflecting ongoing commitment to Alzheimer's research and treatment.



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