The Therapeutic Goods Administration (TGA) has confirmed its initial decision from Oct 2024 not to register lecanemab in Australia for use as an amyloid-lowering therapy for the treatment of mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia (early Alzheimer's disease).
Eisai, the sponsor, pointed out that Australia's regulatory agency is the only one to date that has decided not to register lecanemab, with many other countries including the UK, USA, Japan and China having approved it and the European Medicines Agency giving it a positive recommendation.
The TGA was not satisfied with evidence provided for the safety and efficacy of the drug in people with the APOE4 gene, which increases the risk of developing Alzheimer's disease and is linked with a worse form of the disease.
The TGA proposed limiting the use of the drug to people without the gene, but the company was unwilling to restrict the drug, as "it would unfairly disadvantage those who have been shown to benefit from lecanemab treatment, compared to potential risks".
Eisai proposed that people with APOE4 could be treated in specialist centres and supervised by physicians with expertise in monitoring for amyloid-related imaging abnormalities (ARIA).
However, the TGA was not satisfied that associated wording proposed for the indication would be specific enough to support clinicians and address the outstanding safety concerns for patients.
"Alzheimer's disease is an irreversible neurodegenerative disease that poses significant challenges to those living with the condition, their carers and the community," a spokesperson for Eisai said.
While disappointed with the decision, Eisai and its collaborator Biogen are "optimistic that the results from lecanemab's clinical program, which used validated endpoints agreed upon with health authorities during the trial design and ongoing clinical development, will lead to its registration in Australia in the near future".
"There is a significant unmet need for treatment options that target the underlying cause of disease progression," they said. KB
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