Biogen, Eisai announces TGA of Australia approved LEQEMBI

Eisai and Biogen (BIIB) announced that the Therapeutic Goods Administration, TGA,of Australia has approved the humanized anti-soluble aggregated amyloid-beta monoclonal antibody “LEQEMBI” for mild cognitive impairment or mild dementia due to Alzheimer’s disease in adults who are either ApoE4 non-carriers or heterozygous carriers. In response to February 2025 TGA decision not to approve lecanemab as a treatment for people with early AD, 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.