Leqembi approved for use in Australia
A second treatment for early Alzheimer’s disease targeting amyloid buildup has been registered for use in Australia by the TGA, but Dementia Australia CEO Professor Tanya Buchanan warns that effort is needed to keep access equitable.
The Therapeutic Goods Administration has registered a new amyloid-lowering therapy for adult patients with mild cognitive impairment due to Alzheimer’s disease or early Alzheimer’s disease for use in Australia.
Users must be apolipoprotein Eε4 (APOE4) non-carriers or heterozygotes. The APOE4 gene variant is a predisposing genetic factor for Alzheimer’s disease and approximately 85 per cent of people diagnosed with early Alzheimer’s disease are APOE4 non-carriers or heterozygotes. Heterozygotes refers to people who are non-carriers or have one copy of the APOE4 gene.
Lecanemab, brand name Leqembi, has been registered for use in 49 other countries and is under regulatory review in a further eight countries.
It targets abnormal clumps of the beta amyloid protein which form around the brain cells and interfere with normal cell functions and is administered via a one-hour, fortnightly intravenous infusion.
Leqembi’s approval follows the registration of Donanemab in May, another therapy that targets the buildup of beta amyloid protein on the brain.
Advocates welcome listing
Professionals with Alzheimer’s Global chairman Cathy Roth said registration of the treatment was welcome news for Australians diagnosed with early Alzheimer’s disease.
“The impact of Alzheimer’s disease on Australians living with this disease, their families and carers is profound. These Australians experience stigma, fear, and symptoms that affect their quality of life,” said Ms Roth.
“Early signs and symptoms of mild cognitive impairment, such as often losing things or forgetting important events, may be seen as a normal part of ageing when they are not. Increased early detection, research, and new treatment options for early Alzheimer’s disease are all crucial to give Australians living with this disease, as well as those who sadly may face this diagnosis later in life, new opportunities to manage the progression of the disease.”
Dementia expert and leading geriatrician Professor Michael Woodward said the build-up of toxic amyloid plaques could occur up to 20 years before people experience symptoms. Early diagnosis can provide greater opportunity to reduce the rate of cognitive and functional decline, he said.
“The TGA registration of Leqembi for early Alzheimer’s disease is an important development in the way we treat this disease. It means we now have another amyloid-lowering therapy we can introduce in the right patients to target the underlying cause of Alzheimer’s disease, taking a more proactive approach to slow the cognitive decline associated with the disease. It’s an exciting time but there is work to be done in recalibrating the health system, its resources and focus to fully integrate these therapeutic advances into the effective management of early Alzheimer’s disease,” Professor Woodward said.
Peak warns of side effects, equity concerns
Peak body Dementia Australia has also welcomed the registration of Leqembi, with chief executive officer Professor Tanya Buchanan saying the approval provides hope for people in the early stages of Alzheimer’s disease. But the treatment does come with possible side effects that need to be carefully communicated so patients can make an informed choice, she added.
Side effects of the treatment flagged by Leqembi include amyloid-related imaging abnormalities, or ARIA, which do not always cause symptoms but can be fatal.
ARIA can show up as temporary swelling in parts of the brain and small spots of bleeding in or on the surface can occur. Larger areas of bleeding in the brain can also occur but is less common.
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“With dementia now the leading cause of death for Australians, we welcome any developments that can improve the lives of people living with dementia, their families and carers,” Professor Buchanan said.
“We also need to ensure people understand that lecanemab is not a cure and is only suitable for people in the early stages of Alzheimer’s disease, which is why it is so important for people to receive a timely diagnosis,” she added.
Leqembi is not listed on the pharmaceutical benefits scheme and could cost $40,000 a year, not including the frequent MRIs required to monitor side effects.
As this and other treatments become available in Australia, health systems need to be ready to ensure access to treatment is equitable and available to everyone, Professor Buchanan said.
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