FDA Updates the Fact Sheet for Bebtelovimab
November 4, 2022
The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our
full list of updates.
FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Prescribers should monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1.
There are several treatments that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1.
- Paxlovid is authorized 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 progression to severe COVID-19, including hospitalization or death.
- Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
- Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing 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.
Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19.
FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic.