Swedish research-based biopharmaceutical company BioArctic AB (STO: BIOA-B) announced on Wednesday that the Therapeutic Goods Administration (TGA) of Australia has approved lecanemab, marketed as Leqembi, for the treatment of adult patients with early Alzheimer's disease.

Leqembi stems from a long-standing collaboration between BioArctic and Japanese pharmaceutical company Eisai Co., Ltd. The antibody was originally developed by BioArctic and is already approved in 50 countries including the US, Japan, China and the EU, with an additional 8 countries pending regulatory review.

This latest approval applies to individuals with mild cognitive impairment or mild dementia due to Alzheimer's disease who are apolipoprotein E ε4 non-carriers or heterozygotes, with confirmed amyloid pathology.

The decision follows the TGA's initial rejection of Leqembi in February 2025. Eisai requested a review in March 2025 through the Administrative Review Tribunal, leading to further discussions with the TGA and ultimately a positive outcome.

Eisai holds responsibility for clinical development, regulatory submissions, and global commercialisation. BioArctic retains commercialisation rights in the Nordic region alongside Eisai, and is preparing for a joint market launch of Leqembi in the region.