Emergency Use Authorization (EUA) for the Treatment of COVID-19

Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD).

If you have any questions regarding the procurement of bebtelovimab commercially, please contact AmerisourceBergen Specialty Distributors .

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Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Authorized Use

Bebtelovimab is authorized to be administered 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 risk¹ for progression to severe COVID-19, including hospitalization or death, and
for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Limitations of Authorized Use

Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.
- FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
- FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
Bebtelovimab is not authorized for use in patients, who:
- are hospitalized due to COVID-19, OR
- require oxygen therapy and/or respiratory support due to COVID-19, OR
- require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.
Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19.
Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.

SARS-CoV-2 Viral Variants

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance.

There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Current variant frequency data are available here.

Who is eligible for monoclonal antibody treatments?

Individuals 12 and older who are considered high risk of getting very sick from COVID-19, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration).

Healthcare providers can 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:

Obesity

Chronic Kidney Disease

Cardiovascular Disease / Hypertension

Chronic Lung Disease

Older age

Immunosuppressive Disease / Immunosuppressive Treatment

Diabetes

Pregnancy

These are not all the risk factors. Other risk factors can be 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 bebtelovimab, 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.

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 7 days of symptom onset
Assess if patient is at high risk for progression to severe COVID-19, including hospitalization or death.
Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate.
Identify an infusion center near your patient.
- Refer to the COVID-19 Therapeutic Locator for infusion centers that have received COVID-19 therapeutics or 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 bebtelovimab. Ask the agent to provide you the name and number of the infusion site nearest the patient.
Call the infusion center to confirm product availability.
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/bebtelovimab or the Lilly COVID Hotline (1-855-545-5921) if they have additional questions.

What is bebtelovimab?

Bebtelovimab, pronounced: beb-te-LOV-i-mab

Mechanism of Action

Bebtelovimab is a recombinant neutralizing human IgG1λ monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the F_c region. Bebtelovimab binds the spike protein with a dissociation constant K_D = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC₅₀ value of 0.39 nM (0.056 mcg/mL).

Additional Information for Healthcare Providers:

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab 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.
Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds. 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.

Authorized Use

Bebtelovimab is authorized to be administered 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 risk¹ for progression to severe COVID-19, including hospitalization or death, and
for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Limitations of Authorized Use

Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.
- FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
- FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
Bebtelovimab is not authorized for use in patients, who:
- are hospitalized due to COVID-19, OR
- require oxygen therapy and/or respiratory support due to COVID-19, OR
- require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.
Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19.
Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization.

WARNINGS AND PRECAUTIONS

There are limited clinical data available for bebtelovimab. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care.

Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. These reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:

fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. pre-syncope, syncope), dizziness, and diaphoresis.

Administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.

Clinical Worsening After Monoclonal Antibody Administration

Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%).

USE IN SPECIFIC POPULATIONS
Pregnancy

Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care.

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab.

BB HCP EUA ISI 17MAY2022

¹For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (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.