TGA rejects Alzheimer's drug due to safety concerns

Australia’s Therapeutic Goods Administration (TGA) has made the decision not to register lecanemab (Leqembi) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia (early Alzheimer’s disease).

Developed by pharmaceutical company Eisai, lecanemab is a disease-modifying treatment that works by removing amyloid plaques from the brain and in doing so slows cognitive decline associated with the disease. It is currently approved for use in the UK, USA, Japan, China, South Korea, Hong Kong, the United Arab Emirates and Israel, but was rejected in July by the European Medicines Agency.

In making its decision, the TGA evaluated clinical study data demonstrating that patients treated with lecanemab 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 considered the frequent occurrence of amyloid-related imaging abnormalities (ARIA) — a side effect that involves swelling and potential bleeding in the brain — in patients treated with lecanemab.

Dementia Australia has expressed its disappointment in the TGA’s rejection of the drug, with CEO Professor Tanya Buchanan saying it 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,” 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.

“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.”

Eisai Australia has advised the TGA that it intends to request a reconsideration of the decision under Section 60 of the Therapeutic Goods Act 1989.

Image credit: iStock.com/PIKSEL