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MELBOURNE and SYDNEY, 24 September 2025 – Eisai Australia and Biogen Australia have announced today that the Therapeutic Goods Administration (TGA) has registered the use of LEQEMBI® (lecanemab) in Australia as an amyloid-lowering therapy in adult patients for the treatment of Mild Cognitive Impairment due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease) that are apolipoprotein E ε4 (APOE4) non-carriers or heterozygotes.1,2 Beta amyloid evidence consistent with Alzheimer's disease should be confirmed using a validated test prior to initiating treatment.1
The APOE4 gene variant is a predisposing genetic factor for Alzheimer's disease. Research has shown that approximately 85% of people diagnosed with early Alzheimer's disease are APOE4 non-carriers or heterozygotes, meaning they have no copies (non-carriers), or one copy (heterozygotes) of the APOE4 gene.5,6 LEQEMBI is not indicated for those who carry two APOE4 copies (homozygotes).1
Australia becomes the latest country to register LEQEMBI for use. To date, 49 other countries including the United States and the 27 member countries of the European Union have registered LEQEMBI, with it currently under regulatory review in a further eight countries.7
The TGA registration of LEQEMBI is a significant development, providing a new treatment option for eligible people living with early Alzheimer's disease, based on the results of a rigorous Phase 3 clinical trial.1
Over 400,000 Australians are living with dementia, of which 60% or more may have Alzheimer's disease – a progressive and irreversible neurodegenerative brain disease that impairs cognition, memory and function.3,4 It is characterised by abnormal clumps or 'plaques' of the protein, beta amyloid, which form around the brain cells and interfere with normal cell functions.8 Mild Cognitive Impairment is a brain condition that can be caused by early Alzheimer's disease, and involves subtle changes in memory and thinking.9
LEQEMBI is a monoclonal antibody that is administered in a specialised centre via a one-hour intravenous infusion every two weeks and targets the underlying pathology of Alzheimer's disease.1,2 LEQEMBI works by targeting and lowering toxic amyloid plaques that continuously accumulate in the brain in Alzheimer's disease.1,2
Cathy Roth OAM, Chairman of Professionals with Alzheimer's (PALZ) Global, said this registration is welcome news for Australians diagnosed with early Alzheimer's disease.
"The impact of Alzheimer's disease on Australians living with this disease, their families and carers is profound. These Australians experience stigma, fear, and symptoms that affect their quality of life," said Ms Roth.
"Early signs and symptoms of mild cognitive impairment, such as often losing things or forgetting important events,11 may be seen as a normal part of ageing when they are not. Increased early detection, research, and new treatment options for early Alzheimer's disease are all crucial to give Australians living with this disease, as well as those who sadly may face this diagnosis later in life, new opportunities to manage the progression of the disease."
Leading geriatrician and dementia expert, Professor Michael Woodward, said the TGA registration of LEQEMBI is a significant step as it provides a new treatment option in Australia for people living with early Alzheimer's disease.
"With more than 812,500 Australians projected to be living with a form of dementia by 2054,11 there is an urgent need for advances in the early diagnosis and treatment of Alzheimer's disease. The build-up of toxic amyloid plaques can occur up to 20 years before people may experience symptoms4, so early diagnosis creates greater opportunity to reduce the rate of cognitive and functional decline with new advances in treatment options,"12 said Professor Woodward.
"The TGA registration of LEQEMBI for early Alzheimer's disease is an important development in the way we treat this disease. It means we now have another amyloid-lowering therapy we can introduce in the right patients to target the underlying cause of Alzheimer's disease, taking a more proactive approach to slow the cognitive decline associated with the disease. It's an exciting time but there is work to be done in recalibrating the health system, its resources and focus to fully integrate these therapeutic advances into the effective management of early Alzheimer's disease."
According to Dr John Bower, Market Access and Medical Director at Eisai in Australia, the company is committed to making a meaningful difference to the management and care of people at all stages of Alzheimer's disease
"Australians living with Alzheimer's disease deserve to live their lives in whatever way is most meaningful and fulfilling to them. The TGA registration of this new medicine provides Australians living with early Alzheimer's disease with a treatment option," said Dr Bower.
Monique Alves, Head of Medical Australia and New Zealand at Biogen Australia said, "Working with industry partners, researchers, experts and consumer organisations is important in finding new ways to improve identification, screening, early diagnosis and management of Alzheimer's disease. This announcement is evidence of that and signals a significant step forward to better supporting Australians, their families and carers who are impacted by this disease."
PBS Information: Leqembi is not listed on the PBS
