Sotrovimab FDA Approval Status
Last updated by Judith Stewart, BPharm on Dec 16, 2024.
FDA Approved: No (Discontinued)
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.
On November 22, 2024, GSK requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for sotrovimab since all lots of sotrovimab manufactured and labeled for use under EUA 100 have expired. At the time of GSK’s request, sotrovimab was not authorized for use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility to sotrovimab and regional variant frequency. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.
- 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
| Date | Article |
|---|
| Dec 13, 2024 | FDA Revokes EUA for Sotrovimab for the Treatment of COVID-19 |
| Apr 5, 2022 | FDA Updates Sotrovimab Emergency Use Authorization |
| Mar 25, 2022 | US Food and Drug Administration Revises Emergency Use Authorization for Sotrovimab due to Omicron BA.2 Subvariant |
| Feb 9, 2022 | Data Suggest Sotrovimab Retains Neutralizing Activity Against Omicron Subvariant BA.2 |
| Jan 24, 2022 | Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant |
| Jan 13, 2022 | GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19 |
| Dec 7, 2021 | Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant |
| Dec 2, 2021 | Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-CoV-2 Variant |
| Nov 12, 2021 | Primary Endpoint Met in COMET-TAIL Phase III Trial Evaluating Intramuscular Administration of Sotrovimab for Early Treatment of COVID-19 |
| Jun 21, 2021 | GSK and Vir Biotechnology Announce Continuing Progress of the COMET Clinical Development Programme for Sotrovimab |
| May 26, 2021 | GSK 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, 2021 | Lilly, 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, 2021 | GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19 |
| Mar 10, 2021 | Vir Biotechnology and GSK Announce VIR-7831 Reduces Hospitalisation and Risk of Death in Early Treatment of Adults with COVID-19 |
| Mar 3, 2021 | Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19 |
| Jan 27, 2021 | Lilly, 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, 2020 | Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19 |
| Oct 12, 2020 | Vir Biotechnology and GSK Announce Global Expansion to Phase 3 of COMET-ICE Study Evaluating VIR-7831 for the Treatment of COVID-19 |
| Aug 31, 2020 | Vir Biotechnology and GSK Start Phase 2/3 Study of COVID-19 Antibody Treatment |
Further information
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