Core Viewpoint - The Therapeutic Goods Administration (TGA) of Australia has declined the approval of lecanemab for early Alzheimer's disease, which is a setback for patients and healthcare professionals in Australia [1][3]. Company Summary - BioArctic AB, in collaboration with Eisai, developed lecanemab, which is a humanized monoclonal antibody targeting amyloid-beta (Aβ) aggregates [9][14]. - BioArctic has the right to commercialize lecanemab in the Nordic region and is preparing for joint commercialization with Eisai [7][13]. - The company has no development costs for lecanemab and is entitled to payments related to regulatory approvals and sales milestones [13][14]. Industry Summary - Alzheimer's disease (AD) is the most common cause of dementia, accounting for 60-70% of cases, with a significant unmet need for effective treatments [4]. - The number of people living with dementia in Australia is projected to increase from approximately 411,000 in 2023 to about 849,000 by 2058 [4]. - Lecanemab has been approved in 11 markets, including the U.S., Japan, and the UK, and is based on positive Phase 3 clinical trial results [6][10].
Therapeutic Goods Administration decides not to register lecanemab in Australia