- EUA withdrawn on 11/30/22 due to inadequate neutralization against circulating Omicron sublineage viruses.
- The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of bebtelovimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) patients with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.
*High risk is defined as:
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have diabetes
- Have cardiovascular disease (including congenital heart disease) or hypertension
- Have chronic lung disease
- Are pregnant
- Have sickle cell disease
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Have neurodevelopmental disorders
- Are ≥65 years of age
- Are ≥ 55 years of age AND have cardiovascular disease OR hypertension OR COPD/other chronic respiratory diseases
Bebtelovimab 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
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