Australia's TGA Rejects Alzheimer's Drug Lecanemab, Citing Risk-Benefit Concerns
Key Insights
Australia's Therapeutic Goods Administration (search) (TGA) has rejected lecanemab, an Alzheimer's drug approved in other countries, due to concerns that the risks outweigh the clinical benefits.
Dementia Australia (search) expresses disappointment, noting Australians with early Alzheimer's or mild cognitive impairment will lack access to a treatment available elsewhere.
Lecanemab, administered intravenously, targets amyloid plaques (search) in the brain, a key characteristic of Alzheimer's disease (search), but carries significant risks.
The Therapeutic Goods Administration (search) (TGA) in Australia has rejected lecanemab, a drug designed to slow cognitive decline in early-stage Alzheimer's disease (search). This decision means that Australians with early diagnosed Alzheimer's disease or mild cognitive impairment will not have access to the treatment, which is available in other countries.
The TGA's decision was based on an assessment that the risks associated with lecanemab outweigh its clinical benefits. Lecanemab, administered via intravenous infusion, works by removing amyloid plaques (search) from the brain, a hallmark of Alzheimer's disease (search). While it is not a cure, it has been viewed as a significant step forward in managing the disease.
Dementia Australia (search) CEO Professor Tanya Buchanan expressed disappointment with the TGA's decision, highlighting that it puts Australia behind other countries where lecanemab is approved, including the UK, the US, Japan, China, South Korea, Hong Kong, the United Arab Emirates, and Israel. She noted the potential for risk mitigation through restricted access and post-market surveillance, emphasizing that Alzheimer's is a progressive and fatal condition, and lecanemab is currently the only available treatment to address it.
Cathy Roth, founder of Professionals with Alzheimer's and Related Diseases Group (PALS), shared her disappointment, noting that the prospect of lecanemab's availability in Australia had given hope to many. She anticipates that some individuals may seek the treatment overseas, despite the expense.
Risks vs. Benefits
The TGA's primary concern revolves around the balance between the potential clinical benefits and the significant risks associated with lecanemab. While the drug aims to slow cognitive decline by targeting amyloid plaques (search), it is not without potential adverse effects. The specific nature of these risks was not detailed, but the TGA concluded that they were too significant in relation to the observed clinical benefits.
Context of Alzheimer's in Australia
Data from the Australian Bureau of Statistics indicates that dementia is projected to become the leading cause of death in Australia and is already the leading cause of death among Australian women. This underscores the urgent need for effective treatments and interventions for Alzheimer's disease (search).
Next Steps
The pharmaceutical company responsible for lecanemab has indicated its intention to request a reconsideration of the TGA's decision. This follows a similar rejection by the European Medicines Agency (search) in July. The outcome of this reconsideration will be crucial for the future availability of lecanemab in Australia.