New Alzheimer’s drug approved: This is who will benefit
Are we on the cusp of significantly reducing the prevalence of dementia in Australia? This drug has been found to slow the progression of the most common type of the condition.
A new drug to treat early Alzheimer’s has been given the green light for use in Australia, in a significant boost in the fight against the disease.
The Therapeutic Goods Administration (TGA) said on Wednesday it had approved Leqembi (lecanemab) for adults diagnosed with mild cognitive impairment and mild dementia due to Alzheimer’s disease.
Developed by Eisai Australia and Biogen Australia, Leqembi targets the underlying cause of Alzheimer’s disease to remove and lower amyloid plaques in the brain.
It comes after the TGA also approved the drug Kisunla (donanemab) in May.
Alzheimer’s disease is the most common cause of dementia, with about 50,000 new cases diagnosed in Australia every year. It is an irreversible neurodegenerative brain disease that causes cognition, memory and function impairment.
Dementia-related deaths are now the leading cause of all deaths in Australia.
While both drugs have now been approved in Australia, the next step is a review for subsidy on the Pharmaceutical Benefits Scheme.
They are going through that process now but, in the meantime, patients will need to fund them privately at a cost of at least $80,000 a year.
University of Melbourne Professor Christopher Rowe is the director of the Australian Dementia Network at Austin Health.
He said the approval gave clinicians and their patients choice in which treatment best suited their circumstances and added competition to the field that could lead to lower cost for this form of therapy.
“These treatments bring hope to people with a diagnosis of Alzheimer’s disease and their families,” Professor Rowe said.
“They are the most substantial progress I have seen in decades of treating people with Alzheimer’s disease and other forms of dementia. My hope is that the federal government can make these treatments accessible to all Australians, irrespective of where they live, their background or their income.”
He described the much-anticipated decision to approve leqembi as “exciting”. “It has been shown to slow progression of Alzheimer’s in the criteria set by the TGA by one-third,” Professor Rowe said.
“What is really exciting is that the earlier diagnosed and treated, the benefit increases.”
Professor Rowe said studies emphasised the need for Australians developing memory and thinking problems to go and see their doctor sooner rather than later.
“Don’t put it off,” he said.
Dementia Australia describes the drug, given as an infusion, as a disease modifying treatment for people living with the early stages of Alzheimer’s disease.
Last October the TGA made the initial decision not to approve the drug, which was then upheld in February.
It is now approved it for those with mild disease and who do not carry two copies of the APOE4 gene.
This gene can increase the risk of Alzheimer’s disease and the TGA said its safety in this group of patients had not been satisfactorily established.
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Originally published as New Alzheimer’s drug approved: This is who will benefit
