Marketing authorisation has been granted for donanemab (Kisunla) in Australia, following announcements from Brazil, and Mexico, for the treatment of Alzheimer’s disease.
The authorisations in Brazil and Mexico were granted in April 2025, with the announcement of the Australian approval on 21 May 2025. The authorisations by the Therapeutic Goods Administration inAustralia, Agência Nacional de Vigilância Sanitária in Brazil, and the Comisión Federal para la Protección contra Riesgos Sanitarios in Mexico mean that donanemab can now be considered as a treatment option for individuals with early symptomatic Alzheimer’s disease in these countries. Following these authorisations, Australia, Brazil, and Mexico must assess the treatment according to additional respective national criteria.
These developments have occurred following a different outcome in the European Union. In March 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against granting marketing authorisation for donanemab (Kisunla) for the treatment of mild cognitive impairment or the mild dementia stage of Alzheimer’s disease across the European Union’s Member States and European Economic Area (EEA). Thus, potentially leaving lecanemab as the only disease-modifying therapy likely to achieve marketing authorisation within the EU. From these most recent countries announcing approval of donanemab, Mexico is currently the only country of the three to have authorised lecanemab, with Australia’s Therapeutic Goods Administration having denied market authorisation and Brazil’s Agência Nacional de Vigilância Sanitária yet to share a decision.
The differing regulatory outcomes highlight the varying approaches to the evaluation and approval of Alzheimer’s disease therapies globally. ADI has recently highlighted a growing concern for those travelling for Alzheimer’s treatment, a phenomenon that has grown out of the inconsistencies of regulation throughout the world.
We will continue to monitor these developments and provide updates as they become available.