Dementia Australia ‘disappointed’ after medical watchdog rejects new Alzheimer’s drug

Dementia Australia, the national peak body that supports people living with dementia, said it is “disappointed” after the Therapeutic Goods Administration (TGA) rejected a groundbreaking Alzheimer’s drug for use in Australia.

Unlike current medication, which only treats the symptoms, Lecanemab tackles the disease itself by removing amyloid plaques from the brain, thereby slowing the cognitive decline associated with the disease.

Currently, Lecanemab is approved for use in the UK, USA, Japan, China, South Korea, Hong Kong, United Arab Emirates and Israel.

Dementia Australia Chief Executive Officer Professor Tanya Buchanan said the decision would deprive Australians of the ability to access the potential benefits of the new treatment.

“Dementia Australia is disappointed that Australians living with Alzheimer’s disease in its early stages may be unable to access the same choice of treatments as people living in other countries,” Professor Buchanan said.

“Alzheimer’s disease is a progressive and ultimately fatal neurological condition so slowing decline when people are experiencing mild symptoms is incredibly important in supporting people to maintain quality of life for longer.”

While respectful of the TGA’s position, Professor Buchanan said the decision will be a blow to Australians who could have benefited from the drug.

“Lecanemab is not a cure and is not for all people with a diagnosis of Alzheimer’s disease. Like many medicines it also comes with some significant risks,” she said.

“It is however, widely seen as an historic first step towards reducing the huge impact of Alzheimer’s disease and for people living with the condition it signified hope.”

Representatives for the TGA said they rejected Lecanemab, “on the basis that the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine.”

The TGA explained that the clinical study showed patients treated with Lecanemab saw a reduction in disease progression, however, the difference was not significant enough to provide, “a meaningful clinical benefit or to outweigh the associated safety risks.”

However, Lecanemab’s sponsor, Eisai Australia, has advised the TGA it plans to request a reconsideration of the decision.

Meanwhile, Professor Buchanan is still hopeful that meaningful treatment will soon be available, as currently, more than 100 clinical trials testing treatments for dementia are taking place globally.

“Research released this year also showed that nearly half of all dementia cases globally could be prevented by addressing modifiable risk factors,” she said.

Meanwhile, Australian scientists are leading the fight against Alzheimer’s after developing a first-of-its-kind finger-prick blood test to detect the disease before symptoms progress.

Engineers at Monash University developed a small, handheld device that uses world-first patented sensor technology to detect ultra-low concentrations of disease markers in blood within minutes. This innovation is expected to enable GPs to diagnose Alzheimer’s at an early stage.

Associate Professor Sudha Mokkapati from Monash Materials Science and Engineering, developed the proof-of-concept electronic sensor, stating that the device is “simple to use, low-cost and portable so it could be made widely accessible to GPs to screen patients right at the point-of-care”.

“Detecting very early disease in large populations could dramatically change the trajectory of this burdening disease for many patients, and shave millions off associated healthcare costs,” Mokkapati said.

Given that the number of Australians diagnosed with dementia is set to double by 2054, the quick blood test could provide earlier, more efficient diagnosis, offering timely intervention and management of Alzheimer’s, according to Associate Professor Matthew Pase from Monash’s School of Psychological Sciences.

“Most patients with neurodegenerative disease are typically diagnosed at advanced stages. Sadly, treatments targeting late-onset disease provide limited therapeutic benefit,” Pase said.

“Earlier screening could change the outlook for many patients diagnosed with cognitive impairment through a greater chance of halting or slowing symptom development and the rapid progression of the disease.”

Researchers are now focusing on conducting clinical validation and securing the necessary funding to ensure that the innovation becomes widely accessible.

-with AAP.