New Alzheimer’s Drug Lecanemab Approved in Australia

 



Dementia is now the leading cause of death in Australia. Alzheimer’s disease accounts for 60 to 80 per cent of dementia cases. Recently, Australia’s Therapeutic Goods Administration (TGA) approved lecanemab, a new drug for early Alzheimer’s disease. This follows the approval of donanemab earlier in 2025. Lecanemab aims to slow disease progression but is costly and requires careful monitoring.

What Is Lecanemab?

Lecanemab is a monoclonal antibody drug. Monoclonal antibodies are lab-made proteins designed to target specific molecules. Lecanemab targets amyloid protein in the brain. Amyloid plaques are a key feature of Alzheimer’s disease. The drug helps the immune system remove amyloid deposits to reduce brain damage.

Effectiveness of Lecanemab

A major clinical trial involving 1,734 participants over 18 months showed lecanemab slows Alzheimer’s progression. Participants had early Alzheimer’s or mild cognitive impairment confirmed by PET scans detecting amyloid. The drug reduced disease progression by 27 per cent compared to placebo. This equates to about five months less cognitive decline in the treated group. Some evidence suggests benefits may continue for up to four years. Amyloid levels in the brain dropped but symptoms did not reverse.

Safety and Side Effects

Safety concerns exist with lecanemab. About 12.6 per cent of treated patients developed brain swelling. This risk rose to 32.6 per cent in patients with two copies of the ApoE4 gene. Symptoms of brain swelling included headaches, dizziness, blurred vision, and balance issues, mostly mild. Serious brain bleeds occurred in a few patients on blood thinners, sometimes fatal. Small brain bleeds (microhaemorrhages) were more common with the drug. Regular MRI scans every three months are required to monitor safety.

Cost and Accessibility

Lecanemab costs approximately A$40,000 per year in Australia. The Pharmaceutical Benefits Scheme (PBS) does not currently subsidise it. Treatment involves fortnightly doses for 18 months, then monthly maintenance doses. Additional costs include doctor visits and brain scans. The Pharmaceutical Benefits Advisory Committee (PBAC) has yet to approve lecanemab for PBS listing. PBAC rejected donanemab earlier due to uncertain benefits and high costs.

Who Can Benefit?

Lecanemab is only for early-stage Alzheimer’s patients. It does not cure the disease or improve symptoms. It is ineffective for other types of dementia or advanced Alzheimer’s. Early diagnosis is crucial for treatment eligibility. Patients showing early signs such as memory loss or confusion should seek medical advice promptly.

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