TGA rejects Alzheimer’s medication due to safety concerns

A plan to register lecanemab (sold as LEQEMBI) for patients with mild cognitive impairment due to Alzheimer’s disease and early Alzheimer’s disease has been rejected by the Therapeutic Goods Administration (TGA).
 
In an announcement on Wednesday, the body confirmed it will not register lecanemab ‘on the basis that the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine’.
 
The decision has been met with disappointment from dementia advocacy bodies, who described LEQEMBI as an ‘historic first step towards reducing the huge impact of Alzheimer’s disease’.
 
The medicine is already approved in many countries, including in the United Kingdon, the United States, Japan, and China, and works to slow cognitive decline associated with Alzheimer’s disease by reducing amyloid plaques in the brain.
 
Dementia Australia Chief Executive Professor Tanya Buchanan said the TGA’s decision will ‘deprive Australians of the choice 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,’ she 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.’
 
LEQEMBI’s sponsor, Eisai Australia, has already advised the TGA it intends to request a reconsideration of the decision.
 
Dr Marita Long, a Victorian GP with a special interest in dementia and honorary medical advisor with Dementia Australia, labelled the news disappointing, but said other medications could be on the way in the future.
 
‘There are many additional drugs with encouraging prospects for treating dementia and numerous promising trials are underway,’ she told newsGP.
 
‘Trials using these medications will continue so we will learn more and more, and we will learn from the countries where these drugs have been approved, where they are being used in real life.’
 
‘GPs need to know that these treatments are on the horizon, at this stage they are not curable treatments, they slow progress down.’
 
The TGA’s rejection comes just days after new data from the Australian Bureau of Statistics revealed that dementia is on the brink of becoming the nation’s leading cause of death.
 
It found that the rate for dementia has increased by 843% in the past 50 years and now accounts for 9% of all Australian deaths.
 
But Dr Long said there is much GPs can do in the prevention and management of dementia.
 
‘Optimising brain health throughout the life course, just as we do heart health, remains important,’ she said.
 
‘If we address and modify established risk factors this could prevent or delay onset of 45% of cases of dementia globally, which is a great news story as GPs are excellent at preventive health.
 
‘Dementia Australia is a great resource for anyone concerned about their memory or with a diagnosis of dementia and their carers, it has developed some great resources for GPs, including a GP referrer kit.’
 
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Alzheimer’s disease dementia TGA Therapeutic Goods Administration