There are calls for the Therapeutic Goods Administration (TGA) to greenlight a breakthrough medication with the potential to slow the progression of Alzheimer’s disease.
The Federal Drug Administration (FDA) recently approved humanised monoclonal antibody Lecanemab for use in patients with the neurodegenerative disease, in the wake of promising clinical trial outcomes. The medication, marketed as Lequembi, works by targeting amyloid – a toxic protein that builds up in the brain, essentially ‘poisoning’ important functions.
Researchers observed Lecanemab reduced markers of amyloid in early Alzheimer’s disease, and resulted in moderately less decline in measures of cognition and function than placebo over 18 months.
The study, which involved a total of 1795 participants in the early stages of Alzheimer’s disease, demonstrated Lecanemab could slow the rate of decline in memory, thinking and function, and helped patients manage day-to-day activities.
Lecanemab is intravenously infused into the patient, after which it then enters the brain and clears the amyloid plaques thought to cause cognitive impairment and dementia in Alzheimer’s disease.
It is produced by the bio-pharmaceutical companies Eisai and Biogen.
The role of amyloid in Alzheimer’s disease was first discovered by British geneticist and molecular biologist, Professor Sir John Hardy, more than 30 years ago.
Head of Aged Care Research and the Memory Clinic at Austin Health, Melbourne, and Board member of the Dementia Australia Research Foundation, Associate Professor Michael Woodward, is positive about the findings.
“This is an advancement in our progress towards finding a treatment for Alzheimer’s disease.
“[The medication] is unambiguously effective – a very large trial showed a 27 per cent decline in disease progression in people in the early stages of Alzheimer’s and dementia,” said A/Prof Woodward.
“What this means is that if you took the drug for two years, you would be up to nine months better off, and that is a significant benefit.
“It means nine months longer with our loved ones, nine months longer of doing the things we love,” A/Prof Woodward said.
Dementia is the second leading cause of death in Australia, and without a medical breakthrough, is expected to affect more than one million Australians by 2058.
Unlike many other medications on the market for Alzheimer’s disease, Lecanemab targets the underlying disease process, rather than simply treating symptoms.
Dementia Australia CEO, Maree McCabe AM, welcomed the news of Lecanemab’s approval in the US.
“This announcement provides further hope for people who are developing symptoms and who are in the early stages of Alzheimer’s disease.”
Lecanemab has yet to be approved for Alzheimer’s disease and dementia patients in Australia, but is anticipated to be available for clinical use by the end of 2023.
To listen to the interview with A/Prof Woodward, click here.