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FDA Medication Tracker

← All approvals · Brain & mental health · 2024

Kisunla (donanemab-azbt)

The FDA approved Kisunla (donanemab-azbt) on July 2, 2024 to treat Alzheimer’s disease.
Brand name
Kisunla
Generic name
donanemab-azbt
FDA approval date
July 2, 2024
Approved use (FDA wording)
To treat Alzheimer’s disease
Company
Eli Lilly Co
Application
BLA761248
Dosage form / route
INJECTABLE · INJECTION
Boxed warning on label
Yes (see the FDA label)
Category on this site
Brain & mental health

Indications and usage, from the FDA label

KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.