Eisai will request reconsideration of initial decision for lecanemab in Australia
Stockholm, Sweden October 17, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab