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News|Articles|March 1, 2022
FDA Updates Sotrovimab Emergency Use Authorization
Author(s)Pharmaceutical Technology Editors
FDA has revised the Emergency Use Authorization for sotrovimab.
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FDA updated the Emergency Use Authorization (EUA) for sotrovimab on Feb. 23, 2022 to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment.
This update is in response to FDA’s continuous monitoring of how authorized treatments for COVID-19 are affected by changing variants, which currently include the Omicron variant and Omicron sub-variants.
Sotrovimab is still currently authorized in all US regions. The EUA authorizes sotrovimab to treat positive-testing patients who are at high risk for progression to severe COVID-19, including hospitalization or death. Sotrovimab should be administered via IV as soon as possible after a positive viral test for COVID-19 and within seven days of symptom onset.
FDA will continue to monitor conditions and refer to available information to determine whether use in a geographic region is feasible for authorization.
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