The approval in the US of a new, first-of its kind treatment for Alzheimer’s provides real hope for people in the early stages of the disease, Dementia Australia says.
The US FDA announced on June 7 that it had approved Aduhelm (aducanumab) to treat Alzheimer’s disease.
It’s the first new treatment approved for Alzheimer’s since 2003 and the first therapy to target the fundamental pathophysiology of the disease.
“This treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s.”Patrizia Cavazzoni, US Food and Drug Administration
Researchers trialed the drug in three separate studies involving 3,482 patients, including 100 Australians.
Patients who were given the drug had a significant reduction in amyloid beta plaque associated with Alzheimer’s.
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” the FDA’s Patrizia Cavazzoni said.
Under consideration by TGA
The Australian arm of the drug maker Biogen has applied for aducanumab, which was fast-tracked through the approvals system in the US, to be green-lighted for use in Australia under the standard evaluation pathway, a heath department spokeswoman told Community Care Review.
“The Therapeutic Goods Administration is currently evaluating Biogen Australia’s application,” she said.
“Timeframes for evaluation of individual applications will ultimately depend on when an appropriate data package is provided by the sponsor and fully assessed by the TGA.”
Under review by TGA
Dementia Australia CEO Maree McCabe says it’s the first approval of a disease-modifying drug for Alzheimer’s in 20 years and describes it as exciting news for the global dementia community.
“This announcement provides real hope for people who are developing symptoms and in the early stages of Alzheimer’s disease,” Ms McCabe said.
“Importantly this will result in further research investment into more treatments for all forms of dementia.”
She said an announcement from the TGA about its availability in Australia was expected early next year.
However it may be some time before it is available in Australia, she warned.
Hope for early stages
Dementia Australia medical advisor Associate Professor Michael Woodward said removing amyloid protein could significantly reduce the rate of Alzheimer’s-related decline.
“We can’t bring back brain tissue that has been damaged irreversibly but we can protect brain tissue by removing the toxic effects of this amyloid,” Professor Woodward said.
“It is possible that, if used very early in Alzheimer’s disease, this drug will prevent the emergence of the symptoms of Alzheimer’s, but there is still research to be done in this area.”
He noted that the drug should only be used in the early stages of the disease and may not work for everyone. It also had side effects that needed to be monitored.
According to the FDA, these include temporary swelling of the brain, headaches, diarrhoea and confusion.
Aducanumab was approved under the FDA’s accelerated approval pathway, which enables the fast-tracking of drugs for serious conditions if initial evidence shows they address an unmet medical need.
Biogen is conducting further trials in the US to verify the apparent benefits and the drug may be withdrawn if it fails to do this, the FDA said.
WA researchers launch trial
Meanwhile, Australian researchers have launched clinical trails into the use of the cardiac medication Probucolm as a potential Alzheimer’s treatment.
Probucolm has been found to suppress the production and leakage of small molecules in the blood, protect brain capillaries and improve memory and cognitive function in people living with the disease.
The research is being led by Professor John Mamo of Curtin University and is open to West Australians living with the disease.