Australian regulators have recently approved Lecanemab, a new promising drug that seems to treat early-stage Alzheimer’s disease. In doing so, the Therapeutic Goods Administration (TGA) has reversed its own earlier decision to reject the drug in October last year. Lecanemab, or Leqembi as branded, is aimed at patients experiencing cognitive decline in the early stages of Alzheimer’s. It has shown remarkable success, cutting cognitive decline by nearly 30 percent.
By removing amyloid plaques in the brain, which are linked to the advancement of Alzheimer’s disease, lecanemab essentially stops the development of Alzheimer’s disease. This new approval is actually a sign of a different and more positive trend. Lecanemab has already secured approval in around 50 countries, including the US, the UK, and China. This is the first new treatment option that really addresses the underlying pathology of the disease, and this is really hope for the people diagnosed with Alzheimer’s.
Understanding Lecanemab’s Side Effects
Though Lecanemab is a major breakthrough in treating Alzheimer’s, it does come with hazards. The most serious adverse events are brain swelling or small brain bleeds. In fact, research suggests only 10 percent of those who do not have the APOE4 gene will develop these complications. For those who carry the APOE4 gene, the risk more than triples.
Despite these reactions, the absolute risk of experiencing a serious side effect from Lecanemab is still less than 1 percent. This relatively low risk likely adds to the drug’s allure for both patients and healthcare providers. Regular monitoring with MRI scanning is critical during treatment to detect these negative impacts on the brain as soon as possible.
“What that means is that after the usual 18 months of treatment, you’ve deferred progression of the disease by about six months,” – Professor Chris Rowe
Financial Implications and Treatment Administration
Despite the evidence provided in the Reconsideration Request, the cost of Lecanemab treatment is significant, with one year’s supply costing AUD 39,974 in Australia. Patients pay out-of-pocket expenses for the cost of seeing a specialist for infusion administration and the high cost of frequent MRI scans do add up. These costs add up, in some cases exceeding AUD 100,000 over the duration of treatment.
Given that lecanemab is given by intravenous infusion every two weeks, it is a time-consuming intervention not only for patients but their families. With high costs and extensive logistics involved, patients opting for this complex treatment are faced with making difficult choices.
“So I strongly urge anybody with noticeable memory decline to see their doctor and get assessed early. Don’t put it off because this drug doesn’t work once you get past the mild stage of dementia.” – Professor Chris Rowe
Clinical Evidence and Future Prospects
Lecanemab’s approval was largely justified by a phase-3 trial that recruited about 1,800 patients with early Alzheimer’s disease. The results of this study demonstrated that Lecanemab treatment decreases amyloid plaque biomarkers. As a direct result, studied patients suffered less of a cognitive decline after 18 months.
Professor Chris Rowe highlighted the significance of the clinical results, stating, “One of the reasons the PBS knocked back Donanemab is because they claimed it only gave six weeks’ benefit … but with Lecanemab, all the tests consistently show a six-month benefit, so it may have a better shot of getting PBS approval.” Plus, unpublished long-term studies indicate that the benefits continue even after active treatment ends.
As additional data comes forth from longer studies, there is promise that Lecanemab will pave the way to being a cornerstone in Alzheimer’s therapy. The emphasis on early intervention is sure to produce better outcomes for patients diagnosed with this debilitating condition.
