Treats Alzheimer's disease. BLA 761248, held by Eli Lilly Co. Donanemab-Azbt.
As of Nov 13, 2026, BLA 761248 (Kisunla), held by Eli Lilly Co, was first approved by FDA on Jul 2, 2024, with 1 approved supplement and 1 published complete response letter.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jul 2, 2024 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 18, 2023 | Kisunla (LY3002813)Clinical, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kisunla350MG/20ML(17.5MG/ML) · injectable;injection | Donanemab-Azbt | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
