Bebtelovimab
Generic name: bebtelovimab
Dosage form: injection for intravenous use
Drug class:Miscellaneous antivirals
What is bebtelovimab?
Bebtelovimab is an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (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 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.
There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19.
Bebtelovimab is not authorized for use in people who:
- are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDC’s latest information on circulating variants by geographic area), or
- 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 COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
What is an Emergency Use Authorization?
The United States FDA has made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
Bebtelovimab has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA has determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives.
All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for bebtelovimab is in effect for the duration of the COVID-19 declaration justifying emergency use of bebtelovimab, unless terminated or revoked (after which bebtelovimab may no longer be used under the EUA).
Bebtelovimab is not an FDA-approved medicine in the United States. It is your choice for you or your child to receive bebtelovimab or stop it at any time.
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus...
