Effective April 5th, 2022, sotrovimab distribution has been halted, and the FDA has pulled authorization for use as data suggest it will be ineffective against the Omicron subvariant (BA.2) that is currently the dominant circulating strain in the U.S.
The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of sotrovimab 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. Symptom onset should be within the previous 7 days. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals. The use of sotrovimab is also not authorized in geographic regions where infections are likely caused by a non-susceptible variant (sotrovimab had a 16-fold reduction in activity against variant Omicron BA.2; continue to monitor geographic spread).
*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
Sotrovimab 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, or
- Who live in geographic regions where the infection is likely caused by a non-susceptible variant.
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