Hong Kong approves Leqembi for Alzheimer’s treatment

Leqembi is intended for patients with mild cognitive impairment or at the mild dementia stage of the disease. Leqembi is the first treatment proven to slow the progression of AD.

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.

July 15, 2024