On 16 October, the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the decision not to register lecanemab for the treatment of people with early Alzheimer’s disease (mild cognitive impairment and mild dementia due to Alzheimer's disease). While lecanemab has been approved in the US, Japan, China, South Korea, Hong Kong, Israel and Great Britain, the European Medicines Agency (EMA) issued a negative opinion on the marketing authorisation application for lecanemab in late July. In its opinion, the TGA found that the reduction in disease progression was not deemed significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks. In particular, the TGA considered the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in people receiving lecanemab. This decision was supported by independent expert advice from the TGA's Advisory Committee on Medicines (ACM). Eisai, the sponsor of lecanemab, has announced its intention to request a reconsideration of this decision, with the TGA expected to issue a final decision within 60 days of the request.
https://www.tga.gov.au/news/news/tgas-decision-not-register-lecanemab-leqembi
