Dementia drug rejected by TGA

The Therapeutic Goods Administration (TGA) has decided not to register Alzheimer's drug lecanemab (LEQEMBI) on the basis that "the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine."

Lecanemab is an antibody infusion therapy developed by pharmaceutical company Eisai as a treatment for slow cognitive decline for individuals in the early stages of Alzheimer's disease. The drug is administered intravenously and works by clearing amyloid plaque (a sticky protein that can disrupt cell function) that has built up in the brain of the patient.

While the drug's effectiveness has been debated, testing has shown a slower rate of cognitive decline in those receiving treatment. However, in a statement made by the TGA, it said its reasons for rejecting the drug are based on harm to benefit ratios.

"Clinical study data demonstrated that patients treated with LEQEMBI experienced a reduction in disease progression compared to those given a placebo, however this difference was not deemed significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks."

"In particular, the TGA delegate considered the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in patients treated with LEQEMBI."

Dementia Australia has expressed its disappointment at the decision, calling the rejection a blow for Australians living with Alzheimer's disease.

“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,” Dementia Australia chief Professor Tanya 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."

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“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.”

This is not the first time, however, that lecanemab has been rejected by a national regulator.

While lecanemab is approved for use in USA, Japan, China, South Korea and Israel, the European Medicines Agency (EMA) refused to grant marketing authorisation for lecanemab for reasons similar to the TGA, saying the observed effects of the drug did not outweigh the risk of serious side effects such as swelling and bleeding in the brain.

Similarly, in a whiplash decision, lecanemab was both approved and rejected within 24 hours in the UK.

Following a review of the risks and benefits the Medicines and Healthcare products Regulatory Agency (MHRA) approved lecanemab for use in Great Britain in August of this year, yet later the very same day the National Institute for Health and Care Excellence (NICE) issued draft guidance not recommending lecanemab for use "because it is not a cost effective use of limited NHS funding."

Eisai has advised that they intend to request a reconsideration of the TGA's decision.

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