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Sotrovimab FDA Approval Status

Last updated by Judith Stewart, BPharm on June 16, 2021.

FDA Approved: No (Emergency Use Authorization)
Generic name: sotrovimab
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: COVID-19

Sotrovimab is an investigational monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells in patients with COVID-19.

  • Sotrovimab received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on May 26, 2021. Sotrovimab is not FDA approved for any use.
  • Sotrovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) 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 is not authorized for use in patients who are hospitalized due to COVID-19, or who require oxygen therapy due to COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).
  • Sotrovimab is administered as a single intravenous infusion over 30 minutes.
  • There are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use. Infusion-related reactions, including immediate hypersensitivity reactions, have been observed in patients who received sotrovimab in clinical trials. Other reported side effects include pyrexia, chills, dizziness, dyspnea, pruritus, rash, and diarrhea.

Development timeline for sotrovimab

DateArticle
Apr  5, 2022FDA Updates Sotrovimab Emergency Use Authorization
Mar 25, 2022US Food and Drug Administration Revises Emergency Use Authorization for Sotrovimab due to Omicron BA.2 Subvariant
Feb  9, 2022Data Suggest Sotrovimab Retains Neutralizing Activity Against Omicron Subvariant BA.2
Jan 24, 2022Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
Jan 13, 2022GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19
Dec  7, 2021Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant
Dec  2, 2021Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-CoV-2 Variant
Nov 12, 2021Primary Endpoint Met in COMET-TAIL Phase III Trial Evaluating Intramuscular Administration of Sotrovimab for Early Treatment of COVID-19
Jun 21, 2021GSK and Vir Biotechnology Announce Continuing Progress of the COMET Clinical Development Programme for Sotrovimab
May 26, 2021GSK and Vir Biotechnology Announce Sotrovimab (VIR-7831) Receives Emergency Use Authorization from the US FDA for Treatment of Mild-to-Moderate COVID-19 in High-Risk Adults and Pediatric Patients
Mar 29, 2021Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19
Mar 26, 2021GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19
Mar 10, 2021Vir Biotechnology and GSK Announce VIR-7831 Reduces Hospitalisation and Risk of Death in Early Treatment of Adults with COVID-19
Mar  3, 2021Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19
Jan 27, 2021Lilly, Vir Biotechnology and GSK Announce First Patient Dosed in Expanded BLAZE-4 Trial Evaluating Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19
Dec 17, 2020Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19
Oct 12, 2020Vir Biotechnology and GSK Announce Global Expansion to Phase 3 of COMET-ICE Study Evaluating VIR-7831 for the Treatment of COVID-19
Aug 31, 2020Vir Biotechnology and GSK Start Phase 2/3 Study of COVID-19 Antibody Treatment

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.