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 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 product, bamlanivimab, for the treatment of COVID-19.
- Bamlanivimab has not been approved, but has been authorized for emergency use by FDA.
- Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Health care providers should review the Fact Sheet for information on the authorized use of bamlanivimab 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 is 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.
Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes in 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.
The use of alternative authorized monoclonal antibodies that are expected to retain activity against circulating viral variants may reduce the potential risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone.
How do monoclonal antibodies treat COVID-19?
Monoclonal antibodies, such as bamlanivimab, 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 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 COVID-19 antibody 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 patient 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. 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 is bamlanivimab?
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 0.025 µg/mL.
- Designed to block viral attachment and entry into human cells, thus potentially neutralizing the virus, and treating COVID-19
- Identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19
- Emerged from the collaboration between Eli Lilly and AbCellera™
Instructions for Administration
Bamlanivimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adults 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:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
Are ≥55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory disease.
Are 12 – 17 years of age AND have
- BMI ≥85th percentile for their age and gender based on CDC growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy, OR
- a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease that requires daily medication control.
Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease.
There are no known contraindications for bamlanivimab.
Additional Information for Healthcare Providers:
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab 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 must be administered intravenously. The authorized dosage is a single intravenous (IV) infusion of 700 mg bamlanivimab must be administered over 16-60 minutes, or more, via pump or gravity. Bamlanivimab 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.