BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved lecanemab (Leqembi) for the treatment of adult patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes, with confirmed amyloid pathology.
In response to February 2025 the TGA decision not to approve lecanemab for the treatment for people with early AD, in March 2025, Eisai requested a review by the Administrative Review Tribunal. As a result of the discussions during this process, the TGA and Eisai reached an agreement that led to the approval of Leqembi.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.
More information can be found on the Therapeutic Goods Administration (TGA) of Australia’s website: TGA approves registration of lecanemab (LEQEMBI) | Therapeutic Goods Administration (TGA)
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on September 24, 2025, at 08:40 a.m. CET.
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