Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in Australia
TOKYO and CAMBRIDGE, Mass., Oct 17, 2024 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-solubleaggregated 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 decision under Section 60* of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia…
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