Posted by Michael Wonder on 24 Sep 2025
Leqembi (lecanemab) approved for the treatment of Alzheimer’s disease in Australia
24 September 2025 - Eisai and Biogen announced today that the TGA of Australia has approved the humanised anti-soluble aggregated amyloid-beta monoclonal antibody “Leqembi” (lecanemab) for mild cognitive impairment or mild dementia due to Alzheimer's disease in adults who are either ApoEε4* non-carriers or heterozygous carriers.
In response to February 2025 TGA decision not to approve lecanemab as a treatment for people with early Alzheimers's disease, in March 2025, Eisai requested a review by the Administrative Review Tribunal. As a result of discussions during this process, the TGA and Eisai reached an agreement that led to the approval of Leqembi.
