| Category | Details |
|---|---|
| Event | Lecanemab (Leqembi) approved by Australia's Therapeutic Goods Administration (TGA) for early-stage Alzheimer's treatment. |
| Date of Approval | September 2025 |
| Significance | Second disease-modifying therapy approved in Australia; Alzheimer's is the leading cause of death in the country. |
| Drug Mechanism | Monoclonal antibody targeting amyloid-beta plaques, clearing soluble amyloid protofibrils. |
| Clinical Trial Results | 18-month phase 3 trial with 1,795 participants: 27-30% slower cognitive decline, 5-6 months delay in disease progression, sustained amyloid plaque reduction. |
| Indicated Patients | Early-stage Alzheimer's (mild cognitive impairment or mild dementia), confirmed amyloid plaques, non-carriers or heterozygotes of the APOE ε4 gene. |
| Excluded Patients | Advanced Alzheimer's, other dementia types, patients on blood thinners. |
| Safety Concerns | Risks include brain swelling (ARIA-E: 12.6%, 32.6% in APOE ε4 homozygotes), microhemorrhages (ARIA-H), headaches, dizziness, blurred vision, and rare serious brain bleeds. MRI monitoring required. |
| Cost | Approximately A$40,000 annually, plus MRI scans, doctor visits, and infusion fees. Not yet subsidized under the Pharmaceutical Benefits Scheme (PBS). |
| Accessibility | Limited availability in select memory clinics and specialist centers; PBS coverage pending review by the Pharmaceutical Benefits Advisory Committee (PBAC). |
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