Eisai to Seek Reconsideration of TGA’s Initial Decision on Lecanemab for Alzheimer’s Disease in Australia

TGA's Initial Decision:
The Therapeutic Goods Administration (TGA) of Australia has issued an initial decision not to register lecanemab (sold as Leqembi) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.

Eisai's Response:
Eisai plans to request a reconsideration of this decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia.

Global Approval Status:
Lecanemab is already approved in several countries including the US, Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain for the treatment of MCI due to AD and mild AD dementia.

Reason for Rejection:
The TGA's decision was based on the finding that the benefits of lecanemab did not outweigh the safety risks, particularly the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in patients treated with lecanemab.

Clinical Trial Data:
Clinical study data showed that patients treated with lecanemab experienced a reduction in disease progression compared to those given a placebo, but this difference was not deemed significant enough to provide a meaningful clinical benefit.

Stakeholder Reaction:
Dementia Australia expressed disappointment over the TGA's decision, stating that it would deprive Australians of the choice to access the potential benefits of the new treatment.