The Australian Dementia Network (ADNeT) welcomes the decision by the Therapeutic Goods Administration (TGA) to approve the use of donanemab in Australia.

It is the first drug registered in Australia that has been proven to significantly slow the progression of Alzheimer’s disease. But it needs to be given at the first signs of the disease and closely monitored to avoid serious side effects.

Currently there is an average three-year delay between first signs and getting a diagnosis of AD and waiting times to see dementia specialists in many areas are over a year. Monthly infusions and frequent brain imaging is required when on treatment. To meet the expected demand for this treatment the health system will need to rapidly change.

The TGA decision grants Australians access to a therapy shown to slow decline by one third in persons with Alzheimer’s Disease, the most common cause of dementia in Australia. The approval comes nearly 12 months after donanemab was approved in the United States, with subsequent approvals in Japan, China, and Great Britain.

Donanemab gives greatest benefits to patients when administered soon after a timely diagnosis. A new, more stream-lined approach to diagnosis with investment in GP and specialist education, expansion of Memory Clinics and infusion centres, provision of patient support staff and access to the new AD blood tests to triage those suitable for treatment is needed.

Professor Christopher Rowe MD FRACP, Director of ADNeT, believes that patients with a recent diagnosis of early Alzheimer’s disease will benefit greatly from this therapy, but we need proper diagnostic tools and support to ensure patients can access this treatment in a timely and beneficial manner.

“The day has finally arrived when Australians with early Alzheimer’s disease can access 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. We need broad application of diagnostic blood tests around Australia to ensure GPs can diagnose Alzheimer’s in a timely and accurate manner and open the possibility of their patients receiving these treatments.”

ADNeT is currently running a trial of a blood-based biomarker diagnostic test with GPs across three regions of Australia in Newcastle, Adelaide, and north-east Melbourne. Last week the blood test was approved by the United States Food and Drugs Administration for early diagnosis in adult patients 55 years and older exhibiting signs and symptoms of the disease.

TGA approval and a national roll out of this new diagnostic blood-test could ensure Australians can receive early diagnosis by their GP and access to new treatments in time for them to have the most impact. Professor Rowe on the risks associated with the drug:

“Previous regulatory decisions have raised concerns on potential side effects from donanemab in earlier trials. The risk of serious damage from the drug is about one in 200 when given carefully and to the right patients. I am sure that many patients would gladly accept this risk.”

“We need strict monitoring protocols in place to mitigate the risk of ARIA. Close monitoring with MRI scans is required in the first 6 months of treatment when these problems are most likely to occur.”

Professor Rowe added:

“Today is a momentous day in the treatment of the most common form of dementia. We must now ensure our health system is ready with the diagnostic tools and expert staff to bring these new treatments to patients. Dementia impacts over 400,000 Australians and is the largest cause of death for Australian women.”

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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.

About Dementia:

Alzheimer’s Disease is the most common form of Dementia. 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.

Currently around 433,000 Australians live with dementia, which is expected to increase to an estimated 812,500 by 2054.