For healthcare provider information on bamlanivimab alone, click here.
bamlanivimab and etesevimab
A neutralizing antibody treatment
bamlanivimab 700 mg and etesevimab 1400 mg injection
Emergency Use Authorization (EUA) for the treatment of COVID-19
Bamlanivimab and etesevimab are authorized to be administered together for use for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
- Bamlanivimab and etesevimab administered together has not been approved, but has been authorized for emergency use by the FDA.
- Bamlanivimab and etesevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Limitations of authorized use
Bamlanivimab and etesevimab are not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes with COVID-19 hospitalized patients requiring high flow oxygen or mechanical ventilation.
The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of combination etesevimab and bamlanivimab to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 Infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for etesevimab and bamlanivimab for the treatment of COVID-19.
We are working with the federal government to appropriately plan and allocate supply of bamlanivimab with etesevimab together and plan to communicate more information about the availability of supply in the coming days and weeks.
Over 250,000 doses of bamlanivimab and etesevimab together should be available by the end of Q1 2021. Lilly, along with our partner Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021.
In the meantime, in order to help as many patients as possible, Lilly has already delivered 950,000 doses of bamlanivimab alone and recently agreed to supply another 500,000 doses to the United States no later than March 31. For information on the authorized use of bamlanivimab alone, go to bamlanivimab.com. For additional questions, please contact the Lilly COVID Hotline at 1-855-545-5921.
If you have a question about enrolling a patient in a clinical trial, please visit our Lilly Trial Guide.
Additional information for healthcare providers
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and etesevimab and mandatory requirements of the EUA.
- Healthcare providers should provide a copy of the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish) to patients and/or caregivers prior to treatment.
Bamlanivimab and etesevimab are administered together as a single intravenous infusion. The dosage of bamlanivimab and etesevimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is:
- bamlanivimab 700 mg
- etesevimab 1,400 mg.
- Administer bamlanivimab and etesevimab as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
See more information regarding dosing in the Fact Sheet for Healthcare Providers.
MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or online here.