Dementia Australia is disappointed by the initial decision of the Therapeutic Goods Administration (TGA) to reject Lecanemab for use in Australia. Lecanemab is a disease modifying treatment for people living with the early stages of Alzheimer’s disease or mild cognitive impairment.
Developed by pharmaceutical company Eisai, Lecanemab works by removing amyloid plaques from the brain and in doing so slows cognitive decline associated with the disease.
Lecanemab is currently approved for use in the UK, USA, Japan, China, South Korea, Hong Kong, United Arab Emirates and Israel. In July it was rejected by the European Medicines Agency, a decision that has been criticised by Alzheimer’s Europe.
Dementia Australia CEO Professor Tanya Buchanan said the decision would deprive Australians of the choice to access the potential benefits of the new treatment.
“While we respect the TGA as Australia’s medicines regulator, should this decision be upheld it will be a blow to Australians who may be able to benefit from Lecanemab. 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.
“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. 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.
“While today’s news is a disappointment, we are encouraged by the significant investment in research from prevention through to treatment of dementia. There are currently more than 100 clinical trials of medicines to manage dementia happening globally. Research released this year also showed that nearly half of all dementia cases globally could be prevented by addressing modifiable risk factors.”
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Maybe, just maybe, the TGA is finally starting to screen drugs properly by studying the listed side effects.
Maybe they are applying the precautionary principle.
From drugs.com site “Lecanemab can cause temporary swelling or bleeding in the brain”.
If I had Alzheimers and was capable of reading the list of side effects I would skip it too. But that’s just me.