{"id":177216,"date":"2025-09-29T09:31:05","date_gmt":"2025-09-29T09:31:05","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/177216\/"},"modified":"2025-09-29T09:31:05","modified_gmt":"2025-09-29T09:31:05","slug":"what-is-lecanemab-the-newly-approved-alzheimers-drug-can-it-really-slow-down-dementia","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/177216\/","title":{"rendered":"What is lecanemab, the newly approved Alzheimer\u2019s drug? Can it really slow down dementia?"},"content":{"rendered":"

Dementia is a condition that results in progressive memory or thinking problems. It\u2019s now the most common cause<\/a> of death in Australia.
\nThere are many different causes of dementia, but Alzheimer\u2019s disease accounts for<\/a> around 60\u201380% of all cases. <\/p>\n

Last week, Australia\u2019s Therapeutic Goods Administration (TGA) approved<\/a> a new drug for early Alzheimer\u2019s diseases: lecanemab, sold under the brand name Leqembi. It follows the approval of a similar drug, donanemab, earlier this year. <\/p>\n

But while lecanemab has been shown to slow the progression of disease in some people who receive an early diagnosis, it comes with a high price-tag that will put it out of reach for many Australians. <\/p>\n

How does it work?<\/p>\n

Lecanemab is from a class of drugs known as monoclonal antibodies. <\/p>\n

When our bodies are confronted with foreign \u201cinvaders\u201d, most commonly bacteria or viruses, our immune system responds by producing antibodies. These are proteins that bind to the invader and mark it out to other immune cells for destruction. <\/p>\n

A monoclonal antibody is produced in a lab to bind to a specific target: in this case, the amyloid protein that is the microscopic hallmark of Alzheimer\u2019s. <\/p>\n

Once the immune system captures the antibody, it can then remove amyloid from our brains in order to limit ongoing damage. <\/p>\n

How effective is it?<\/p>\n

The local approval comes as a result of a large clinical trial<\/a> of 1,734 participants over 18 months, which was funded by the drug company Eisai. <\/p>\n

The trial showed a significant slowing of disease progression in a large group of patients who had either early Alzheimer\u2019s or mild cognitive impairment due to early changes of Alzheimer\u2019s in the brain. <\/p>\n

Before the trial, all patients had positron emission tomography (PET) scans showing the presence of amyloid protein in their brain.<\/p>\n

Those who received the active drug during the study progressed 27% less compared to those who were given placebo over the 18 months. This was measured by a scale of both cognition and function, known as the Clinical Dementia Rating Sum of Boxes.<\/p>\n

Over the 18-month study period, this equates to about five months\u2019 less decline in the group who received lecanemab. <\/p>\n

For patients who have continued treatment, evidence of continued benefit for as long as four years has recently been presented<\/a>.<\/p>\n

Participants who received lecanemab also showed large reductions in the levels of amyloid in the brain, as measured by a PET scan. By the end of the trial, the majority of participants were considered to be below the threshold that would normally indicate the presence of Alzheimer\u2019s, but it did not reverse their symptoms.<\/p>\n

What are the side effects?<\/p>\n

Regulators have raised concerns about safety. The TGA previously rejected the drug\u2019s approval on the basis of its risk and benefit profile<\/a> when it originally considered the application in October last year. <\/p>\n

Some 12.6% of trial participants receiving the drug experienced brain swelling. The rates rose to 32.6% in those possessing two copies of an Alzheimer\u2019s-promoting gene, apolipoprotein E4 (ApoE4). <\/p>\n

Of those who experienced brain swelling, 22% had side effects such as headaches, dizziness, blurred vision and balance problems. These were generally mild, but a small number of participants who were also prescribed blood-thinning medications during the study had serious brain bleeds<\/a> that resulted in death. The remaining 78% of those who developed brain swelling experiencing no symptoms from this. <\/p>\n

Due to the risk of brain swelling, those taking the drug require three-monthly MRI scans to monitor their brain.<\/p>\n

Some 17.3% of those on active drug also experienced small bleeds into the brain (microhaemorrhages), compared to 9.0% of those taking placebo.<\/p>\n

Last year\u2019s TGA rejection of lecanemab was appealed, and new<\/a> safety and outcome data out to four years of treatment were presented as part of the appeal process. <\/p>\n

How much does it cost?<\/p>\n

Australia\u2019s Pharmaceutical Benefits Scheme (PBS) does not currently subsidise<\/a> lecanemab. It costs<\/a> the equivalent of A$40,000 per year, placing it beyond the reach of many who might benefit from it. <\/p>\n

Guidelines recommend<\/a> dosing at fortnightly intervals for an 18-month period, with monthly \u201cmaintenance\u201d dosing thereafter. <\/p>\n

There are also costs associated with the monitoring required to ensure the safety and efficacy of the drug (doctors\u2019 visits, MRI and PET scans).<\/p>\n

The Pharmaceutical Benefits Advisory Committee (PBAC) has not yet considered lecanemab for PBS listing. <\/p>\n

However, PBAC rejected an application for a similar drug, donanameb, for PBS listing in July, citing concerns that the benefits were \u201ctoo small and uncertain to justify the burden of this treatment on both patients and the health system\u201d. <\/p>\n

Lecanemab works in a similar way to donanemab, which received TGA approval<\/a> earlier this year. Both drugs have similar costs<\/a>, efficacy and risks.<\/p>\n

Bottom line<\/p>\n

Lecanemab can only be used in the early stages of Alzheimer\u2019s. If you or a loved one are experiencing early signs of Alzheimer\u2019s diseases, such as consistent short-term memory loss or confusion about days and dates, it\u2019s important to seek medical advice early, to obtain an accurate diagnosis and to clarify your treatment options.<\/p>\n

If you\u2019re considering lecanemab or donanemab, it\u2019s important to know these drugs are not cures for Alzheimer\u2019s disease. They may slow the progression, but they don\u2019t improve the symptoms. <\/p>\n

Lecanemab won\u2019t benefit those whose dementia is caused by conditions other than Alzheimer\u2019s, nor will it benefit those with Alzheimer\u2019s whose disease has progressed beyond its earliest stages.<\/p>\n","protected":false},"excerpt":{"rendered":"Dementia is a condition that results in progressive memory or thinking problems. It\u2019s now the most common cause…\n","protected":false},"author":2,"featured_media":177217,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[64,63,137,490],"class_list":{"0":"post-177216","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-au","9":"tag-australia","10":"tag-health","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/177216","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=177216"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/177216\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/177217"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=177216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=177216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=177216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}