Australia steadfast on rejection of Eisai, Biogen’s Alzheimer’s therapy Leqembi

Australia's Therapeutic Goods Administration (TGA) has rejected the approval of lecanemab (brand name Leqembi), an Alzheimer's disease treatment developed by Eisai and Biogen, citing safety concerns1 2. Here are the key details:

Decision and Rationale

The TGA decided not to register lecanemab for patients with mild cognitive impairment due to Alzheimer's disease and early Alzheimer's disease1.
The regulatory body stated that "the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine"1 5.

Impact and Reactions

Dementia advocacy groups expressed disappointment, describing Leqembi as a "historic first step towards reducing the huge impact of Alzheimer's disease"1 4.
Dementia Australia CEO Professor Tanya Buchanan stated that the decision will "deprive Australians of the choice to access the potential benefits of the new treatment"4.

Next Steps

Eisai, the drug's sponsor, has announced its intention to request a reconsideration of the decision within 90 days2.
The company aims to make lecanemab available for eligible people living with early Alzheimer's disease in Australia2.

Global Context

Lecanemab is already approved in several countries, including the United States, Japan, China, South Korea, and the United Kingdom2 4.
The drug works by removing amyloid plaques from the brain, potentially slowing cognitive decline associated with Alzheimer's disease4.

Significance

The rejection comes as dementia is approaching becoming Australia's leading cause of death, with rates increasing by 843% over the past 50 years1.
While not a cure, lecanemab is seen as an important step in managing Alzheimer's disease progression, particularly in its early stages4.

The TGA's decision highlights the ongoing debate surrounding the efficacy and safety of new Alzheimer's treatments, as regulators weigh potential benefits against associated risks.

Sources:

1. https://www1.racgp.org.au/newsgp/clinical/tga-rejects-alzheimer-s-medication-due-to-safety-c

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

4. https://www.dementia.org.au/media-centre/media-releases/drug-rejection-blow-australians-living-alzheimers

5. https://www.beingpatient.com/where-is-leqembi-approved-for-alzheimers/