17 October 2024 - Eisai announced today that the TGA of Australia issued a public statement about the initial decision not to register the humanised anti-soluble aggregated amyloid beta monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer's disease dementia.

Eisai will request a reconsideration of this decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early Alzheimer's disease in Australia. Following Eisai’s request for review, the TGA will issue a final decision within 60 days of receiving Eisai’s request.

Read Eisai press release