TGA doubles down on rejection of Alzheimer’s drug
The Australian Therapeutic Goods Administration (TGA) has confirmed its decision not to register Alzheimer's disease drug lecanemab (LEQEMBI).
Lecanemab is an antibody infusion therapy, developed by pharmaceutical company Eisai, which has been shown to slow cognitive decline 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) from the brain of a patient.
The TGA first rejected the therapy in October 2024, on the basis that “the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine,” however, Eisai was quick to request a review of this decision in December.
On Tuesday, the TGA again refused to register the drug for Australian market.
Eisai responds
“We are extremely disappointed and surprised by the TGA’s decision and understand that the AD community in Australia may also feel disheartened, especially given that 11 countries and regions across the globe have granted marketing authorisation," Eisai chief clinical officer Lynn Kramer MD said.
"We tried earnestly to reach a compromise with the TGA on an indication that would adequately represent the data in the application but were unfortunately unsuccessful at this time."
“The TGA proposed a narrow indication that would limit access to only ApoE4 noncarriers. This indication would deny approximately two-thirds (~70 per cent) of all potentially eligible patients access to a treatment that could slow the progression of AD. Eisai believes ApoE4 heterozygote carriers should at least also have access to lecanemab given the similar benefit-risk profile to the noncarrier population. Therefore, we could not accept this restrictive indication as it is not patient-centric.
“Given this outcome, we are deeply concerned that Australians living with Alzheimer’s disease will not have access to a treatment that slows the progression of early Alzheimer’s disease by targeting its underlying causes.
“Eisai remains committed to ensuring eligible Australians with early Alzheimer’s disease can access lecanemab and is exploring options to achieve this, including potentially seeking review by the Administrative Review Tribunal.”
While the TGA is not the only regulatory body to raise concerns over the drug's safety and efficacy, it has been approved for use in 11 countries, including the United States, Japan, China, Hong Kong, Israel, South Korea, the United Arab Emirates, Great Britain and by the European Medicines Agency. Leaving Australia as the only country to reject the drug.
Disappointment and frustration
Australian Dementia Network director Professor Christopher Rowe echoed the disappointment expressed by Eisai, arguing that with proper monitoring protocols the risks associated with lecanemab, such as amyloid-related imaging abnormalities (ARIA), could be successfully mitigated.
“I had hoped that from today, it would be a new world for persons with early Alzheimer’s disease. That when I gave my patients the devastating news that they have Alzheimer’s disease, I could offer them a new treatment that for the first time is proven to slow the disease,” he said.
“This drug buys valuable time, slowing the rate of progression towards severe dementia by one third. The risk of serious damage from the drug is about one in 100 when given carefully and to the right patients. I am sure that many patients would gladly accept this risk.
“In my decades treating patients with Alzheimer’s, these new drugs are the first proven to slow the progression of this relentless and eventually fatal disease for which there is no cure. With the same safeguards in place in other similar countries where lecanemab is approved, Australians should have access to this treatment.”
Related: "Shiny new treatment:" High cost means new Alzheimer's drugs not available to all | Dementia drug rejected by TGA | FDA approves drug for early symptomatic Alzheimer’s disease
Alzheimer’s Research Australia (ARA), an organisation which conducts extensive clinical research and drug development trials for the disease, expressed support for the consumer's right to choose.
ARA chief Professor Vicky Vass said the treatment had become a representation of hope for many Australians affected by Alzheimer's and other forms of dementia, “my gran suffered from Alzheimer’s, and if a treatment like lecanemab had been available, we would have hoped for its approval,” she said.
“As a family, we were all impacted, as we watched our mum suffer, as her mum deteriorated, and as grandchildren, we slowly lost our best friend and biggest supporter.
“It is critical that we consider the needs and voices of all of those affected.”
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