Donanemab: First Approval

Drugs. 2024 Oct;84(10):1313-1318. doi: 10.1007/s40265-024-02087-4. Epub 2024 Sep 6.

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.

Publication types

  • Review

MeSH terms

  • Alzheimer Disease* / drug therapy
  • Amyloid beta-Peptides / antagonists & inhibitors
  • Amyloid beta-Peptides / immunology
  • Amyloid beta-Peptides / metabolism
  • Antibodies, Monoclonal, Humanized / pharmacology
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Cognitive Dysfunction / drug therapy
  • Drug Approval*
  • Humans
  • United States
  • United States Food and Drug Administration

Substances

  • Antibodies, Monoclonal, Humanized
  • Amyloid beta-Peptides
  • donanemab