The Therapeutic Goods Administration (TGA) of Australia has approved lecanemab (Leqembi), developed collaboratively by BioArctic and Eisai, for the treatment of adult patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (early AD), specifically in individuals who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.

Leqembi is a humanized IgG1 monoclonal antibody that targets both aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). The therapy is the result of a long-standing partnership between BioArctic and Eisai.

Eisai manages the clinical development, regulatory approvals, and global commercialisation of Leqembi, while BioArctic retains the right to commercialise the therapy in the Nordic region in collaboration with Eisai, with joint commercialisation plans underway.

Following the TGA’s initial decision in February 2025 not to approve lecanemab for early AD, Eisai requested a review by the Administrative Review Tribunal in March 2025. Discussions during this process led to an agreement between the TGA and Eisai, culminating in the approval of Leqembi.

Currently, lecanemab is approved in 50 countries, including the US, Japan, China, and the European Union, for treating patients with MCI or mild dementia due to Alzheimer’s disease. It is under regulatory review in eight additional countries. In the U.S., Leqembi Iqlik™ is approved as a subcutaneous injection for maintenance dosing in early AD.

BioArctic, a Swedish research-based biopharmaceutical company, focuses on innovative therapies aimed at delaying or halting the progression of neurodegenerative diseases. Beyond Leqembi, BioArctic’s pipeline includes antibodies targeting Parkinson’s disease, ALS, and other Alzheimer’s disease-related projects.