THE Therapeutic Goods Administration (TGA) has decided that it will not register Lecanemab (LEQEMBI), a medication for people living with mild cognitive impairment and the early stages of Alzheimer's disease, as "the demonstrated efficacy did not outweigh the safety risks".
The medication works by removing amyloid plaques from the brain, slowing down cognitive decline in patients.
While clinical study data showed that the disease's progression was reduced in people using the medication compared to those given a placebo, according to the TGA, it was not deemed "significant enough to provide a meaningful clinical benefit".
Lecanemab is currently approved for use in the UK, USA, Japan, China, South Korea, Hong Kong, United Arab Emirates and Israel, with the company expected to request a reconsideration.
Dementia Australia CEO Professor Tanya Buchanan expressed her dismay of the TGA's decision, describing it as "a blow to Australians" who are in the early stages of Alzheimer's disease.
"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," she said.
"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."
According to the Australian Institute of Health and Welfare, last year, it was estimated that 411,100 Australians live with dementia and Alzheimer's disease. JHM
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