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Flagship Alzheimer’s drug deemed too risky to launch in Australia

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Flagship Alzheimer’s drug deemed too risky to launch in Australia

The Therapeutic Goods Administration (TGA) has decided not to register Lecanemab, an Alzheimer’s drug that has been shown to reduce for use in Australia.
Trials of the drug in the UK showed it slowed a person’s cognitive decline by around a quarter to a third.
Lecanemab was subsequently approved for use in the United Kingdom, the United States, and a number of other countries.
It is the that modifies the disease—and not just the symptoms—of the most common form of dementia
But the TGA said on Wednesday: “The demonstrated effectiveness did not outweigh the safety risks associated with the use of this medicine” in explaining why it did not register the drug.
Dr Emer MacSweeney heads the private company that led the UK trial of Lecanemab, which tested the drug in people with Alzheimer’s, the most common form of dementia.
“Any drug that can slow this process and also herald the start of a new era of other new drugs designed to be able to stop this disease in its tracks is great news,” he said.

But MacSweeney acknowledged that the drug can have fatal consequences and can cause swelling or bleeding in the brain.

This is a side effect called ARIA, which stands for Amyloid-Related Imaging Abnormalities.
“(A) 35% of people taking this class of drugs will develop ARIA, but only 3.5% of people will experience any symptoms,” he said.

“A small group of people, around 0.6%, may develop more serious side effects.”

What was behind the TGA’s decision?

The TGA acknowledged that the drug improved patient outcomes compared with a placebo, but said the safety risks were too great.
“… the demonstrated efficacy did not outweigh the safety risks associated with the use of this drug,” he said.

“In particular, the TGA delegate considered the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in patients.”

Lecanemab sponsor Eisai Australia says it intends to seek a reconsideration of the TGA’s decision.
It is not the first time that the drug has been rejected by a regulator.
In July, the European Medicines Agency refused marketing authorization for the drug, saying: “the benefits of the treatment are not great enough to compensate for the risks.”
“Although the majority of ARIA cases in the main study were not severe and did not involve symptoms, some patients had serious events, such as large brain bleeds that required hospitalization. The severity of this side effect it should be considered in the context of the small effect seen with the drug,” he said.
Lee-Fay Low, professor of aging and health at the University of Sydney’s Faculty of Medicine and Health, called the decision “disappointing”.
“Although there have been risks associated with the drug, it would have been of benefit to people with mild cognitive impairment or early Alzheimer’s disease and has shown promising results for people in these groups,” he said.
“It is important that we take a public health approach to dementia prevention. Exercise, lowering cholesterol and lowering blood pressure, as well as staying active into old age, can contribute to reduce the risk of dementia.

“The government should also invest in memory clinics and increase capacity for early diagnosis and post-diagnosis support.”

Drugs, a “historic first step”

Dementia Australia CEO Professor Tanya Buchanan says the decision deprives Australians of their right to choose.
“Lecanemab is not a cure and it is not for everyone with a diagnosis of Alzheimer’s disease. Like many medicines, it also carries some significant risks,” he said.

“Nevertheless, it is widely seen as a historic first step in reducing the enormous impact of Alzheimer’s disease and for people living with the disease it meant hope.”

Buchanan described the TGA’s rejection as disappointing, but said there is continued investment in Alzheimer’s and dementia research.

“There are currently more than 100 clinical trials of drugs to manage dementia globally. Research published this year also showed that nearly half of all dementia cases globally could be prevented by addressing modifiable risk factors.” .

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