Donanemab: The dawn of disease-modifying treatment for Alzheimer's disease in Australia.

Abstract

On 22 May 2025, the Therapeutic Goods Administration (TGA) announced that the anti-amyloid monoclonal antibody donanemab (Eli Lilly, Kisunla) was approved in Australia for the treatment of Alzheimer's disease (AD). This has been heralded by some as a breakthrough for the treatment of AD, reflecting a turning point from symptomatic treatments to disease-modifying therapies. Psychiatrists should understand this scientific context, as it underpins both the hope and the limits of what donanemab can achieve. The roll-out of disease-modifying treatment comes with significant challenges but also provides a unique opportunity to improve care for people with AD and other dementias.