The Australian Dementia Network (ADNeT) is very disappointed with the decision by the Therapeutic Goods Administration (TGA) to again reject the use of lecanemab in Australia.

This decision denies Australians access to a therapy shown to slow decline by one third in Alzheimer’s Disease, the most common cause of dementia in Australia. The therapy has been approved in 11 countries including the United States, Japan, China, Hongkong, Israel, South Korea, United Arab Emirates, and Great Britain and the European Medicines Agency advisory panel has recommended approval. Australia now stands alone as the only country to not approve this drug.

Professor Christopher Rowe MD FRACP, Director of ADNeT, maintains that patients with a recent diagnosis of early Alzheimer’s disease should have the opportunity to access this treatment once they and their family and carers are fully informed of the benefits and risks.

“I had hoped that from today, it would be a new world for persons with early Alzheimer’s disease. That when I gave my patients the devastating news that they have Alzheimer’s disease, I could offer them a new treatment that for the first time is proven to slow the disease. This drug buys valuable time, slowing the rate of progression towards severe dementia by one third. The risk of serious damage from the drug is about one in 100 when given carefully and to the right patients. I am sure that many patients would gladly accept this risk.”

“In my decades treating patients with Alzheimer’s, these new drugs are the first proven to slow the progression of this relentless and eventually fatal disease for which there is no cure. With the same safeguards in place in other similar countries where lecanemab is approved, Australians should have access to this treatment.”

The TGA based its decision on concerns that the benefits of lecanemab did not outweigh the safety risks, particularly the occurrence of amyloid-related imaging abnormalities (ARIA) seen in clinical trials. In considering the appeal from its original rejection in October 2024, the TGA deemed that the proposed more careful selection of patients for treatment based on exclusion of persons who carried two ApoE-e4 genes did not improve safety and benefit enough to justify approval even though this same change was sufficient for the European Union medical experts to reverse their initial negative recommendation and it mirrors the conditions for use approved by the UK authorities.

Professor Rowe added:

“Countries overseas have approved lecanemab with monitoring protocols and excluding carriers of two e4 genes. We hoped that the TGA would apply the same conditions here, but the restrictions sought by the TGA go much further and would rule out 50-70% of otherwise suitable patients.”

“Alzheimer’s is the most common form of dementia, a disease that impacts over 400,000 Australians and is the largest cause of death for Australian women. We are again urging the TGA to collaborate with international regulators and the pharmaceutical industry to find a way that allows Australians to receive this treatment.”

In countries where lecanemab is available, strict monitoring protocols are implemented to mitigate the risk of ARIA. The risks are markedly higher in persons who carry two APOE-e4 genes, so the UK and European Union authorities have excluded these persons from the treatment while the US FDA has advised extra care. Close monitoring with MRI scans is required in the first 6 months of treatment when these problems are most likely to occur.

Dementia is the largest disease burden in older Australians, progressively erases memories, alters personalities, and diminishes daily capabilities leading to severe incapacity and death over an average period of 8 years from diagnosis.

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Media Enquiries:

Professor Christopher Rowe is available for interviews.

Director, Australian Dementia Network, University of Melbourne

Direct Mobile: +61 (0) 419 110 348

Email: Christopher.Rowe@austin.org.au

About:

The Australian Dementia Network (ADNeT) is a partnership of leading dementia researchers from

across 21 universities and research institutions in Australia, led by the University of Melbourne. For

more information about ADNeT’s work visit: www.australiandementianetwork.org.au.