TGA Declines Registration of Lecanemab

At Alzheimer’s Research Australia, we are acutely aware of the disappointment and frustration felt by patients, families, caregivers, and health professionals following the decision not to approve lecanemab as a treatment for Alzheimer’s disease in Australia. For many, lecanemab represented hope—an opportunity to slow the progression of this devastating illness and improve the quality of life for those in its early stages. This decision highlights the complexity of balancing potential benefits with the associated risks that come with new treatments.

However, we believe it is essential to consider patient choice, especially for conditions like Alzheimer’s that profoundly impact individuals and their families. People living with Alzheimer’s, and those close to them, should be given the opportunity to explore and make decisions on, all available options when it comes to their care.

Lecanemab has already been approved in the United States, United Kingdom, Japan, China, South Korea, Hong Kong, United Arab Emirates, and Israel. However, the European Medicines Agency rejected its approval in July, a decision that has been criticized by Alzheimer’s Europe. The TGA based its decision on concerns that, while lecanemab shows a significant reduction in disease progression, the demonstrated efficacy did not outweigh the associated safety risks, particularly the occurrence of amyloid-related imaging abnormalities (ARIA).

At Alzheimer’s Research Australia, we remain committed to a holistic approach that encompasses prevention, early detection, and the development of effective treatments. We continue to champion research efforts that aim to provide safe and effective solutions for Alzheimer’s and related dementias.

As Professor Vicky Vass, our CEO, shares, “My gran suffered from Alzheimer’s, and if a treatment like lecanemab had been available, we would have hoped for its approval. As a family, we were all impacted, as we watched our mum suffer, as her mum deteriorated, and as grandchildren, we slowly lost our best friend and biggest supporter. It is critical that we consider the needs and voices of all of those affected.”

Professor Ralph Martins, AO, Director of Research at Alzheimer’s Research Australia, highlights, “While the TGA’s concerns about safety are valid, it’s important to recognise that these risks can be managed with proper patient selection and monitoring. In other countries where lecanemab is approved, strict protocols, including MRI scans, help mitigate the potential risk of ARIA. It’s crucial that we work towards providing Australians with the same opportunities to access these potential benefits under comprehensive and carefully controlled conditions.”