Swedish research-based biopharma company BioArctic has announced that its partner Eisai has received approval from Hong Kong’s Department of Health for Leqembi for the treatment of Alzheimer’s disease (AD).
The move marks the fifth approval for Leqembi, following those in the US, China, Japan and South Korea.
Leqembi, a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody, has been developed through a strategic research alliance between BioArctic and Eisai.
The medication is intended for patients with mild cognitive impairment or at the mild dementia stage of the disease, aligning with the population targeted in clinical trials.
The approval is grounded in the results of the Phase III Clarity AD study, which demonstrated that the drug met its primary endpoint and all key secondary endpoints with statistically significant outcomes.
Leqembi selectively binds to both soluble and insoluble amyloid-beta aggregates, believed to play a crucial role in the development of AD, thus reducing these aggregates in the brain.
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Leqembi is the first treatment proven to slow the progression of the disease and the decline in cognitive and functional abilities.
Eisai holds responsibility for the clinical development, market approval applications, and commercialisation of Lecanemab for AD.
BioArctic will receive payments linked to regulatory approvals and sales milestones, along with a 9% royalty on global sales.
The company retains the right to commercialise Leqembi in the Nordic region, subject to European approval. The company is currently preparing for joint commercialisation with Eisai in this region.
In April 2024, BioArctic and Eisai signed an agreement for a research evaluation focusing on BAN2802, a treatment candidate for AD.
BAN2802 combines BioArctic’s BrainTransporter technology with an undisclosed Alzheimer’s drug candidate.
