KISUNLA (Eli Lilly Australia Pty Ltd)
Product name
KISUNLA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
223 (255 working days)
Active ingredients
donanemab
Registration type
NCE/ NBE
Indication
KISUNLA is indicated for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and Mild Alzheimer’s dementia (Early Symptomatic Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or noncarriers.
Beta amyloid evidence consistent with Alzheimer’s disease (AD) should be confirmed using a validated test prior to initiating treatment.