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FDA updates Sotrovimab emergency use authorization

Feb 28 2022

[2/25/2022] The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron subvariants.

On February 23, 2022, FDA revised the emergency use authorization for sotrovimab 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. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA.

For other limitations and conditions, refer to the emergency use authorization (EUA).

FDA will continue to monitor conditions to determine whether use in a geographic region is consistent with the scope of authorization, referring to available information, including information on variant susceptibility and CDC regional variant frequency data.

This EUA authorizes sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Sotrovimab should be administered by a qualified health care provider as a single intravenous infusion (IV) as soon as possible after positive viral test for COVID-19 and within seven days of symptom onset.



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