Australia Rejects Eisai’s Alzheimer’s Drug Leqembi

The Therapeutic Goods Administration (TGA) of Australia has confirmed its decision to decline approval of lecanemab (brand name Leqembi) for the treatment of early Alzheimer's disease14.

The TGA initially rejected Leqembi in October 2024. Eisai requested reconsideration in December 2024, but the TGA has now upheld its original decision45.

The TGA determined that the demonstrated efficacy of Leqembi did not outweigh the safety risks associated with the treatment6.

Eisai expressed disappointment with the decision, stating it would deny approximately 70% of potentially eligible patients access to a treatment that could slow Alzheimer's progression4.

Leqembi has been approved in 11 other countries/regions, including the US, Japan, China, and the UK14.

Eisai remains committed to making Leqembi available in Australia and is exploring options, including potentially seeking review by the Administrative Review Tribunal14.

The rejection is seen as a setback for Australians living with Alzheimer's disease, with an estimated 411,000 people affected in 2023 and projected to increase to 849,000 by 20584.

Sources:

1. https://www.thepharmaletter.com/australia-s-leqembi-rejection-sad-for-all-patients

4. https://us.eisai.com/press-releases/eisai-receives-regulatory-review-outcome-for-lecanemab-as-a-treatment-for-early-alzheimers-disease-in-australia

5. https://www.eisai.com/news/2024/news202476.html

6. https://www.tga.gov.au/news/news/tgas-decision-not-register-lecanemab-leqembi