Lecanemab gains TGA approval for Alzheimer’s treatment in Australia
25 Sep 2025
Lecanemab, sold under the brand name LEQEMBI, is now available for adult patients diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s. It is an amyloid-lowering therapy, and doctors must confirm evidence of beta-amyloid consistent with Alzheimer’s before starting treatment.
This follows the TGA’s approval of Donanemab (Kisunla) in May, the first new treatment for early Alzheimer’s in Australia in 25 years.
Professor Tanya Buchanan, CEO of Dementia Australia, welcomed the announcement. She said the approvals mark an exciting time for dementia treatment but emphasised that lecanemab is not a cure.
“Lecanemab does have potential side effects that need careful discussion so patients can make informed decisions,” Professor Buchanan said. “It is only suitable for people in the early stages of Alzheimer’s, which is why timely diagnosis is so important.”
Lecanemab was initially rejected by the TGA last year due to safety concerns. Additional information provided by the medication’s sponsor, Eisai Australia, addressed these issues, leading to its approval.
Recent figures from the Australian Institute of Health and Welfare show that dementia is now the leading cause of death in Australia, highlighting the importance of treatments that can slow disease progression.
Source: newsGP
