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# FDA Cuts Sotrovimab EUA Regions
- URL: https://www.fdaweb.com/fda-cuts-sotrovimab-eua-regions/
- Published: 2022-03-30T12:00:00.000Z
- Updated: 2026-09-14T17:38:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151490

FDA says that sotrovimab is not authorized in HHS regions 5, 9, and 10 as of 3/30 because the Centers for Disease Control and Prevention says that the proportion of Covid-19 cases caused by the omicron BA.2 variant is above 50% in those regions. An agency [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization?utm%5Fmedium=email&utm%5Fsource=govdelivery) says that under terms of the emergency use authorization, sotrovimab is authorized to treat 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.

The authorization was updated 2/23 to clarify that sotrovimab is not authorized for treating mild-to-moderate Covid-19 in geographic regions where the infection is likely to have been caused by a variant that is not susceptible to the treatment. HHS regions 1 and 2 were taken off the authorized list as of 3/25.

The therapy remains authorized in the remaining HHS regions where the CDC estimates that the proportion of the omicron BA.2 variant remains below 50%. FDA says it will continue to monitor BA.2 in all regions and may revise the authorization further to ensure that Covid-19 patients have effective treatments available.