Australia reverses course with approval of Leqembi for early Alzheimer’s

Swedish biotech BioArctic (Nasdaq Stockholm: BIOA B) said today that Australia’s Therapeutic Goods Administration has approved Leqembi (lecanemab) for certain adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease.The move comes months after an earlier rejection, in February.

Eisai (TYO: 4523) had challenged that decision through the Administrative Review Tribunal, reaching an agreement with the regulator that resulted in approval. The ruling follows the May 2025 registration of Kisunla (donanemab) from US pharma major Eli Lilly (NYSE: LLY), highlighting growing momentum for disease-modifying Alzheimer’s drugs in the country.

Leqembi was developed from BioArctic’s discovery of the Arctic mutation, with Eisai leading clinical development and commercialization. BioArctic will retain rights in the Nordic region, where the partners are preparing a joint launch. Globally, Leqembi is now approved in over 50 countries, including the USA, Japan, China and the EU.