FDA

• EUA withdrawn on 11/30/22 due to inadequate neutralization against circulating Omicron sublineage viruses.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