Experts label TGA’s decision to not register Alzheimer’s drug ‘extremely disappointing’

A drug that could hold the key to delaying symptoms of devastating Alzheimer’s disease will not be made available in Australia, despite the pain and large number of deaths it causes.

A much-anticipated drug that holds the promise of delaying symptoms of Alzheimer’s disease will not be available in Australia.

The decision on Wednesday by the Therapeutic Goods Administration (TGA) not to register the drug lecanemab (LEQEMBI) means it can’t be supplied here.

The news has been described as “extremely disappointing” by Australia’s leading dementia researchers and peak bodies.

Alzheimer’s disease is the most common cause of dementia with around 50,000 new cases diagnosed in Australia every year.

Dementia-related deaths are now a leading cause of all deaths in Australia.

Alzheimer’s disease is the most common cause of dementia.

“When we have Alzheimer’s disease emerging as a common cause of death in older Australians and we have the first treatment on the horizon that can actually change the course of the disease at least to some degree, for the TGA to make a negative decision is extremely disappointing.

“That’s the sentiment of the majority of leading dementia researchers in Australia,” leading neurologist and dementia researcher, Professor Christopher Rowe, said.

The University of Melbourne’s Prof Rowe is also the director of the Australian Dementia Network at Austin Health.

He said leading dementia groups were responding strongly to the decision and expressing their disappointment and the lack of choice it was giving to Australians to make an informed decision about whether they wanted to have the treatment or not.

Dementia Australia describes the drug, given as an infusion, as a disease modifying treatment for people living with the early stages of Alzheimer’s disease.

The drug, it says, includes antibodies designed to attach and remove amyloid plaques. The accumulation of these in the brain is linked to the development of the disease.

In a statement the TGA said it had decided not to register the drug on the basis that the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine.

It said in particular, clinical data demonstrated that patients treated with the drug 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 outweigh the associated safety risks.

Patients treated with the drug experienced a reduction in disease progression.

The US, Japan, China, South Korea, Israel, Hong Kong, the United Arab Emirates and Great Britain have approved the drug.

Professor Rowe said there was still hope in Australia as the drug maker Eisai Australia had launched an appeal on what the TGA was calling an interim decision.

The TGA said Eisai Australia had advised it intends to request a reconsideration of the decision.

Eisai Australia said in a statement it remains committed to working with the TGA so that suitable Australians have access to a treatment option that can make a difference to those living with early Alzheimer’s disease.