Australia’s Leqembi rejection ‘sad for all patients’

The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for early Alzheimer’s disease (AD).

Nonetheless, Japanese drugmaker Eisai (TYO: 4523) has stressed that it remains committed to ensuring eligible Australians with early AD can access the drug and is exploring options to achieve this, including potentially seeking review by the Administrative Review Tribunal.

Leqembi has so far been approved in 11 markets including the USA, Japan, China and the UK. Regulatory filings for the treatment have been made in the European Union (EU) and 17 other countries and regions.