LEQEMBI (Eisai Australia Pty Ltd)
Product name
LEQEMBI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
471 (255 working days)
Active ingredients
lecanemab
Registration type
NCE/ NBE
Indication
LEQEMBI is indicated in adult patients with a diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes.
Beta amyloid evidence consistent with Alzheimer’s disease (AD) should be confirmed using a validated test prior to initiating treatment