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:
Sotrovimab is NOT authorized for use in patients:
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