Donanemab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Amyloid beta |
| Clinical data | |
| Trade names | Kisunla |
| Other names | LY3002813, donanemab-azbt |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6452H10038N1708O2013S42 |
| Molar mass | 145089.74 g·mol−1 |
Donanemab, sold under the brand name Kisunla, is a monoclonal antibody used for the treatment of Alzheimer's disease.[1][2] Donanemab was developed by Eli Lilly and Company.[3][4]
The most common side effects include amyloid-related imaging abnormalities, which are brain hemorrhages and brain swelling, which can cause strokes, seizures, falls and trouble thinking. Brain hemorrhage and swelling occurred in 36.8% of patients taking donanemab and 14.9% of placebo patients.[5] Headache and allergic reactions to the medication were other common side effects.[2]
Donanemab was approved for medical use in the United States in July 2024.[2][6][7] Most of the members of the FDA advisory panel had financial conflicts of interest.[5] Treatment is intended for people with mild cognitive impairment or mild dementia stage of disease, which is the same population the treatment was studied in the clinical trials.[8] Several public interest groups spoke out in FDA hearings against approval of the drug.[9]
- ^ a b "Kisunla- donanemab-azbt injection, solution". DailyMed. 2 July 2024. Archived from the original on 26 December 2024. Retrieved 15 August 2024.
- ^ a b c "FDA approves treatment for adults with Alzheimer's disease". U.S. Food and Drug Administration (FDA) (Press release). 2 July 2024. Archived from the original on 2 July 2024. Retrieved 2 July 2024. This article incorporates text from this source, which is in the public domain.
- ^ Cite error: The named reference
mintunwas invoked but never defined (see the help page). - ^ Long JM, Holtzman DM (October 2019). "Alzheimer Disease: An Update on Pathobiology and Treatment Strategies". Cell. 179 (2): 312–339. doi:10.1016/j.cell.2019.09.001. PMC 6778042. PMID 31564456.
- ^ a b Lenzer J, Brownlee S (September 2024). "Donanemab: Conflicts of interest found in FDA committee that approved new Alzheimer's drug". BMJ. 386: q2010. doi:10.1136/bmj.q2010. PMID 39322239.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 30 April 2024. Retrieved 29 November 2024.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
- ^ "FDA approves treatment for Alzheimer's disease - The Yucatan Times". 12 July 2024. Archived from the original on 15 July 2024. Retrieved 15 July 2024.
- ^ "UPDATED PUBLIC PARTICIPATION INFORMATION: June 10, 2024: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement - 06/10/2024". U.S. Food and Drug Administration (FDA). 26 July 2024. Retrieved 17 March 2025.