Emergency Use Authorization (EUA) for the Treatment of COVID-19
The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of bamlanivimab and etesevimab together to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved products, bamlanivimab and etesevimab together, for the treatment of COVID-19.
- Bamlanivimab and etesevimab together have not been approved, but have been authorized for emergency use by the FDA.
- Bamlanivimab and etesevimab together are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of 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.
- Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).
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 together 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 when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
Who is eligible for monoclonal antibody treatments?
Individuals 121 or older who are considered high risk of getting very sick from COVID-19 may qualify for a monoclonal antibody treatment.
Healthcare providers can now consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to:
Other factors may include neurodevelopmental disorders, sickle cell disease, medical-related technological dependence or other factors found on the CDC website.
Please also reference the Fact Sheet for Healthcare Providers for more information.
How do monoclonal antibodies treat COVID-19?
Monoclonal antibodies, like bamlanivimab and etesevimab together, are designed to help provide passive immunity by giving the body antibodies to protect itself. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines.
The EUA issued by the FDA permits the emergency use of bamlanivimab and etesevimab together for the treatment of mild to moderate coronavirus disease 2019 (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.
On this website you can find more information on these treatment options, including what to do when your patient tests positive for COVID-19 and/or how to set up an infusion site at your hospital or healthcare institution. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921.
My patient tested positive for COVID-19. What do I do next?
Confirm that your patient:
- Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing
- Is within 10 days of symptom onset
- Is an adult or pediatric patient (12 years of age and older and weighing at least 40kg)
- Assess if patient is at high risk for progressing to severe COVID-19 and/or hospitalization.
Identify an infusion center near your patient.
- Call the Lilly COVID Hotline at 1-855-545-5921. Explain to one of our dedicated medical professionals that you are a healthcare provider and that one of your patients is COVID-positive and may meet the criteria for use of bamlanivimab and etesevimab together. Ask the agent to provide you the name and number of the infusion site nearest the patient.
- Write the order.
- Provide your patient with resources to ensure they have the answers they need. You can also direct your patients to LillyAntibody.com or the Lilly COVID Hotline (1-855-545-5921) if they have additional questions.
What are bamlanivimab and etesevimab?
Etesevimab, pronounced: (e-te-SEV-i-mab)
Bamlanivimab, pronounced: (bam” la niv’ i mab)
Mechanism of Action
Bamlanivimab is a recombinant neutralizing human IgG1κ monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region. Bamlanivimab binds to spike protein with a dissociation constant KD = 0.071 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.17nM (0.025 µg/mL).
Etesevimab is a recombinant neutralizing human IgG1κ mAb to the spike protein of SARS-CoV-2, with amino acid substitutions in the Fc region (L234A, L235A) to reduce effector function. Etesevimab binds the spike protein with a dissociation constant KD = 6.45 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.32 nM (0.046 µg/mL).
Bamlanivimab and etesevimab bind to different but overlapping epitopes in the receptor binding domain (RBD) of the S-protein. Using both antibodies together is expected to reduce the risk of viral resistance.
Instructions for Administration
Bamlanivimab and etesevimab together should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adult patients and pediatric patients (12 years of age and older weighing at least 40 kg), who are at high risk for progressing to severe COVID-19 and/or hospitalization.
High risk is defined as patients who meet at least one of the following criteria:
- Older age (for example age ≥65 years of age)
- Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19))
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of bamlanivimab and etesevimab under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.
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 together and mandatory requirements of the EUA.
- Healthcare providers must 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 together must be administered intravenously. The authorized dosage is a single intravenous (IV) infusion of 700 mg bamlanivimab and 1,400 mg etesevimab administered 21-60 minutes or longer via pump or gravity. Bamlanivimab and etesevimab together should be administered 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.