BioArctic AB’s Partner Eisai Announces Approval of Leqembi® (樂意保®) for Alzheimer’s Disease Treatment in Hong Kong

11 July 2024 | Thursday | News

The approval of Leqembi in Hong Kong is grounded in the findings of the large global Phase 3 Clarity AD study. This study demonstrated that Leqembi achieved its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 and older are living with dementia, and 32% of those aged 85 and older, with 73.5% of these cases attributed to Alzheimer’s disease.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

BioArctic AB  is pleased to announce that its partner, Eisai, has received approval from the Department of Health in Hong Kong for Leqembi® (brand name in Hong Kong: "樂意保®", generic name: lecanemab) for the treatment of Alzheimer’s disease (AD). Leqembi is recommended for initiation in patients with mild cognitive impairment (MCI) or mild dementia, mirroring the patient population in clinical trials. Hong Kong marks the fifth approval for Leqembi, following the United States, Japan, China, and South Korea.

 

Leqembi operates by selectively binding to both soluble amyloid-beta (Aβ) aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which constitute a major component of Aβ plaques in Alzheimer’s disease. This binding reduces both Aβ protofibrils and Aβ plaques in the brain, making Leqembi the first approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline through this mechanism.

Leqembi is the culmination of a long-standing collaboration between BioArctic and Eisai, initially developed by BioArctic based on the pioneering work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai oversees the clinical development, market approval applications, and commercialization of lecanemab for Alzheimer’s disease. BioArctic bears no development costs for Leqembi in Alzheimer’s disease and is entitled to payments related to regulatory approvals, sales milestones, and a 9 percent royalty on global sales. Additionally, BioArctic holds the rights to commercialize Leqembi in the Nordic region pending European approval, with joint commercialization preparations currently underway by Eisai and BioArctic in this region.

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