> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Companies Seek Expanded Sotrovimab EUA
- URL: https://www.fdaweb.com/companies-seek-expanded-sotrovimab-eua/
- Published: 2022-01-13T12:00:00.000Z
- Updated: 2026-09-14T17:28:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150925

GlaxoSmithKline and Vir Biotechnology have asked FDA to approve an expanded emergency use authorization (EUA) for the Covid-19 monoclonal antibody treatment sotrovimab to include intramuscular administration. FDA approved the sotrovimab EUA 5/2021 as an investigational single-dose intravenous infusion for the early treatment of SARS-CoV-2.

The companies [say](https://www.marketwatch.com/press-release/gsk-and-vir-submit-emergency-use-authorization-application-to-fda-for-intramuscular-administration-of-sotrovimab-for-the-early-treatment-of-covid-19-2022-01-13?tesla=y&ref=fdaweb.com) the application is based on the Phase 3 COMET-TAIL trial that achieved its primary endpoint in demonstrating that 500mg intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to 500mg intravenous administration for the early treatment of mild-to-moderate Covid-19 in high-risk, non-hospitalized adults and adolescents.