Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2024 Oct;84(10):1313-1318.
doi: 10.1007/s40265-024-02087-4. Epub 2024 Sep 6.

Donanemab: First Approval

Connie Kang  1
Affiliations
Review

Donanemab: First Approval

Connie Kang. Drugs. 2024 Oct.

Erratum in

Abstract

Donanemab (donanemab-azbt; KisunlaTM) is an amyloid β-directed antibody developed by Eli Lilly and Company for the treatment of Alzheimer's disease. Donanemab recently received approval in the USA for the treatment of adults with early symptomatic Alzheimer's disease (patients with mild cognitive impairment or mild dementia stage of disease). This article summarizes the milestones in the development of donanemab leading to this first approval for Alzheimer's disease.

PubMed Disclaimer

References

    1. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512–27. - DOI - PubMed - PMC
    1. Mintun MA, Lo AC, Duggan Evans C, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. 2021;384(18):1691–704. - DOI - PubMed
    1. Eli Lilly and Company. Lilly's Kisunla™ (donanemab-azbt) approved by the FDA for the treatment of early symptomatic Alzheimer's disease [media release]. 2 Jul 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kis... .
    1. Eli Lilly and Company. KISUNLA (donanemab-azbt) injection, for intravenous use: US prescribing information. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf . Accessed 15 Aug 2024.
    1. Gueorguieva I, Willis BA, Chua L, et al. Donanemab population pharmacokinetics, amyloid plaque reduction, and safety in participants with Alzheimer’s disease. Clin Pharmacol Ther. 2023;113(6):1258–67. - DOI - PubMed

MeSH terms

LinkOut - more resources