donanemab
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Indications
- investigational agent to treat Alzheimer's disease
Drug interactions
- antiplatelet drugs increase risk intracerebral hemorrhage
- anticoagulants increase risk of intracerebral hemorrhage
- thrombolytic agents increase risk of intracerebral hemorrhage
Mechanism of action
- immunoglobulin G1 monoclonal antibody directed against insoluble, modified, N-terminal truncated form of beta-amyloid present only in established amyloid plaques
Clinical trials
- small phase 2 trial[1]
- granted breakthrough therapy designation
- Eli Lilly will seek accelerated approval
- claims showed signs of slowing cognitive decline & improving activities of daily living in early Alzheimer's disease[1][2]
- donanemab slows clinical progression in symptomatic Alzheimer's disease with beta-amyloid & tau pathology at 76 weeks[6]
Notes
- FDA has denied accelerated approval Jan 2023
- Lily announces donanemab significantly slowed cognitive and functional decline in phase 3 study of early Alzheimer's disease[5]
More general terms
Additional terms
References
- ↑ 1.0 1.1 1.2 George J Novel Alzheimer's Drug Appears to Slow Decline - Donanemab shows positive results in small phase II study, says drugmaker. MedPage Today January 11, 2021 https://www.medpagetoday.com/neurology/alzheimersdisease/90636
George J Novel Anti-Amyloid Slows Cognitive Decline in Phase II Alzheimer Trial. Though benefit was limited in 76-week study, specialists see reasons for optimism. MedPage Today March 13, 2021 https://www.medpagetoday.com/neurology/alzheimersdisease/91625
Brause D Novel Alzheimer's Drug Slows Cognitive Decline in Phase 2 Trial Medscape - Mar 13, 2021. https://www.medscape.com/viewarticle/947410
Mintun MA, Lo AC, Duggan Evans D Donanemab in Early Alzheimer's Disease. N Engl J Med 2021; 384:1691-1704. May 6, Online: March 13, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33720637 https://www.nejm.org/doi/full/10.1056/NEJMoa2100708 - ↑ 2.0 2.1 Hung WH Alzheimer's Disease Treatment on the Horizon or False Dawn? Medscape - Jul 14, 2021. https://www.medscape.com/viewarticle/954015
- ↑ Shcherbinin A, Evans CD, Lu M et al Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes. The TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. Published online September 12, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36094645 https://jamanetwork.com/journals/jamaneurology/fullarticle/2795844
- ↑ Bender E FDA Says No to Accelerated Approval for Alzheimer's Drug Medscape. Jan 20, 2023 https://www.medscape.com/viewarticle/987276
- ↑ 5.0 5.1 Lily Investors. News Release. May 3, 2023 Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional
- ↑ 6.0 6.1 Sims JR, Zimmer JA, Evans CD et al Donanemab in Early Symptomatic Alzheimer Disease. The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. Published online July 17, 2023 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37459141 PMCID: PMC10352931 Free PMC article https://jamanetwork.com/journals/jama/fullarticle/2807533