Contents

Search

bamlanivimab (LY-CoV555)

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: - nausea 3.9% - dizziness 3.2% - mild infusion reactions 2.3% * infusion site must be able to manage anaphylaxis [3] Mechanism of action: - binds to ACE2 receptor-binding domain of SARS-CoV2 spike glycoprotein [3]

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

monoclonal antibody to spike glycoprotein of SARS-CoV2 (COVID-19)

References

  1. 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. 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. 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. 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: 33356051 https://www.nejm.org/doi/full/10.1056/NEJMoa2033130
  5. 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: 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: 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
  6. 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
  7. 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. 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. 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: 34081073 https://jamanetwork.com/journals/jama/fullarticle/2780870 - Kuritzkes DR Bamlanivimab for Prevention of COVID-19. JAMA. Published online June 3, 2021 PMID: 34081075 https://jamanetwork.com/journals/jama/fullarticle/2780873
  10. 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. 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: 34260849 https://www.nejm.org/doi/full/10.1056/NEJMoa2102685
  12. American Medical Association (AMA) AMA Morning Rounds. Jan 25, 2022