​Summary

Bebtelovimab (LY-CoV1404; LY3853113) is a monoclonal antibody directed against the spike protein of SARS-CoV-2.

On February 11, 2022, the U.S. Food and Drug Administration (FDA) authorized the emergency use of bebtelovimab for the treatment of COVID-19 under an emergency use authorization (EUA) (PDF).

The drug is authorized to treat mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk of progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. Treatment should be initiated as soon as possible after a positive viral test for SARS-CoV2 (either antigen or molecular PCR test) and within 7 days of symptom onset.

Laboratory testing has demonstrated that bebtelovimab retains neutralizing activity against the omicron variant, including the BA.2 subvariant.

For more information on the use of bebtelovimab for the treatment of high-risk, nonhospitalized patients with mild to moderate COVID-19, please refer to the NIH treatment guidelines.

Clinical Trial Data

Interim results from a phase 1/2 clinical trial have shown improved symptoms with bebtelovimab in patients with mild to moderate COVID-19 and a 34% relative reduction in viral load on Day 5 among low-risk patients who received bebtelovimab compared to placebo. The trial was not powered or designed to determine a difference in the clinical outcomes of hospitalization or death between placebo and bebtelovimab.

Bebtelovimab and SARS-CoV-2 Variants

Laboratory based studies have shown that bebtelovimab has neutralizing activity against the Omicron variant. Bebtelovimab is expected to be effective against all variants currently circulating in California, including Omicron and the BA.2 subvariant.

Additional Use Considerations

Bebtelovimab is authorized for treatment only; bebtelovimab is not authorized for prophylaxis. The Fact Sheet for Health Care Providers (PDF), which includes variant data as well as the full conditions of use, should be reviewed prior to administration of the medication.

The following should be considered:

• Treatment should be initiated as soon as possible after a positive viral test for SARS-CoV2 (either antigen or PCR test) and within 7 days of symptom onset. CDPH recommends initiating treatment as soon as the positive results have been obtained, as early treatment is expected to have the most benefit.
• High-risk criteria include older age, being overweight/obese, pregnancy, chronic kidney disease, diabetes, immunosuppression, cardiovascular disease or hypertension, chronic lung diseases, sickle cell disease, neurodevelopmental disorders, having a medical-related technological dependence, or other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19. Authorization for use of anti-SARS-CoV-2 monoclonal antibody treatment is not limited to the medical conditions or factors listed above. Healthcare providers should consider the benefit-risk for an individual patient. Please refer to the CDC's webpage: Underlying Medical Conditions Association with Higher Risk for Severe COVID-19 for more information on medical conditions that place a patient at increased risk for disease progression.
• Bebtelovimab is administered by intravenous injection.
• Bebtelovimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy and/or respiratory support due to COVID-19, or who require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19.
• Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis.
• Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Although rare, there is the potential for serious hypersensitivity reactions, including anaphylaxis with administration of SARS-CoV-2 monoclonal antibodies (see full EUA prescribing information in the Fact Sheet for Health Care Providers [PDF]).
• Health care providers are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths considered to be potentially attributable to bebtelovimab.
• Health care providers must communicate information consistent with the Fact Sheet for Patients, Parents and Caregivers (PDF) and provide a copy prior to the patient receiving bebtelovimab.
• Bebtelovimab is not authorized for treatment of 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 and regional variant frequency. FDA updates are on the FDA's Emergency Use Authorization webpage.

Patient Prioritization During Times of Limited Supply

The National Institutes of Health (NIH) treatment guidelines on prioritization should be followed during times when supply is limited.

Acquiring Bebtelovimab

Distribution amounts for each state/territory is determined by HHS. The California Department of Health (CDPH) will be allocating product to local jurisdictions, once the number of doses has been allocated, each jurisdiction's Medical and Health Operational Area Coordinator (MHOAC) will assist in determining which facilities within the jurisdiction receive product.