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# GSK/Vir Sotrovimab EUA Excludes New Variant Use
- URL: https://www.fdaweb.com/gsk-vir-sotrovimab-eua-excludes-new-variant-use/
- Published: 2022-03-25T12:00:00.000Z
- Updated: 2026-09-14T17:38:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151459

FDA has amended a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab, an investigational monoclonal antibody used in Covid-19 patients, because the 500mg therapy is unlikely to be effective against the Omicron BA.2 variant. The agency based its decision on the “totality of available evidence, including new live virus data generated by Vir,” the companies say. “GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion.” The companies say FDA has updated its Web site to exclude sotrovimab use in geographic regions where infection is likely to have been caused by the variant.