bamlanivimab (LY-CoV555)
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Introduction
FDA-approved Nov 9, 2020
Indications
- treatment of COVID-19 in non-hospitalized adults > 65 with certain chronic medical conditions[1]
- emergency use authorization for persons >= 12 years & >= 40 kg at high risk for progressing to severe COVID-19 &/or hospitalization[3]
* reduces need for hospitalization or emergency room visits in high-risk adults with COVID-19[1]
* bamlanivimab monotherapy reduces Covid-19 infection in nursing home residents & staff at high risk of SARS Cov2 exposure (8.5% vs 15.2% for placebo)[9]
* insufficient evidence to recommend use for treatment of COVID-19[2] or hospitalized COVID-19 patients[3]
* bamlanivimab in combination with etesevimab reduces viral load at day 11[5][11]
- bamlanivimab monotherapy does not[5]
- combination reduces hospitalizations & death for early COVID-19[5][12]
Contraindications
- does not improve outcomes in hospitalized patients with COVID-19 or if hypoxic[4]
- bamlanivimab + etesevimab not effective against B.1.351 (Beta) or P.1 (Gamma) variants[8][10] or Omicron variants[11] (off market Jan 2022)
Dosage
- single IV infusion of 700 mg over 60 minutes*
* of 3 doses use in clinical trial 700, 2800 & 7000 mg, only 2800 mg dose better than placebo in decreasing viral load from baseline on day 11[3]
Adverse effects
* infusion site must be able to manage anaphylaxis[3]
Mechanism of action
- binds to ACE2 receptor-binding domain of SARS-CoV2 spike glycoprotein[3]
More general terms
References
- ↑ 1.0 1.1 1.2 AMA Medical News. Nov 10, 2020 American Medical Association
FDA News Release. Nov 9, 2020 Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19 - ↑ 2.0 2.1 NIH COVID-19 Treatment Guidelines. Nov 18, 2020. The COVID-19 Treatment Guidelines Panel's Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19. https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 From The Medical Letter on Drugs and Therapeutics An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19. JAMA 2020. Dec 11 https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2020.24415
- ↑ 4.0 4.1 ACTIV-3/TICO LY-CoV555 Study Group A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med 2020. Dec 22. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33356051 https://www.nejm.org/doi/full/10.1056/NEJMoa2033130
- ↑ 5.0 5.1 5.2 5.3 Gottlieb RL, Nirula A, Chen P et al Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19A Randomized Clinical Trial. JAMA. Published online January 21, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33475701 https://jamanetwork.com/journals/jama/fullarticle/2775647
Malani PN, Golub RM. Neutralizing Monoclonal Antibody for Mild to Moderate COVID-19. JAMA. Published online January 21, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33475716 https://jamanetwork.com/journals/jama/fullarticle/2775645
Lily Investors. News Release. March 10, 2021 Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19. https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-and-etesevimab-together-reduced - ↑ Chen P, Nirula A, Heller B et al SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med 2021; 384:229-237. Jan 21 https://www.nejm.org/doi/full/10.1056/NEJMoa2029849
Walker M Drugmaker: Antibody Prevents COVID in Nursing Home Patients - May answer questions about the therapy's clinical utility that previous trials did not. MedPage Today January 21, 2021 https://www.medpagetoday.com/infectiousdisease/covid19/90822 - ↑ U.S. Department of Health and Human Services Bamlanivimab Outpatient Monoclonal Antibody Treatment for COVID-19 Made Available under Emergency Use Authorization March 24, 2021 Update on COVID-19 variants and impact on bamlanivimab distribution. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab/Pages/default.aspx
- ↑ 8.0 8.1 NIH COVID-19 Treatment Guidelimes. April 21, 2021 Anti-SARS-CoV-2 Monoclonal Antibodies. https://www.covid19treatmentguidelines.nih.gov/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
- ↑ 9.0 9.1 Cohen MS, Nirula A, Mulligan et al Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities. A Randomized Clinical Trial. JAMA. Published online June 3, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34081073 https://jamanetwork.com/journals/jama/fullarticle/2780870
Kuritzkes DR Bamlanivimab for Prevention of COVID-19. JAMA. Published online June 3, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34081075 https://jamanetwork.com/journals/jama/fullarticle/2780873 - ↑ 10.0 10.1 Walker M U.S. Pauses Use of Lilly's Monoclonal Antibody Combo for COVID. Bamlanivimab and etesevimab not active against all viral strains. MedPage Today June 28, 2021 https://www.medpagetoday.com/infectiousdisease/covid19/93313
- ↑ 11.0 11.1 11.2 Dougan M, Nirula A, Azizad M et al Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021. July 14. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34260849 https://www.nejm.org/doi/full/10.1056/NEJMoa2102685
- ↑ 12.0 12.1 American Medical Association (AMA) AMA Morning Rounds. Jan 25, 2022