Sotrovimab

Sotrovimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Trade namesXevudy
Other namesVIR-7831, GSK4182136
AHFS/Drugs.comMonograph
MedlinePlusa621037
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
UNII
KEGG
A vial of Sotrovimab

Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2.[10][12][13] It was developed by GlaxoSmithKline and Vir Biotechnology, Inc.[12][14] Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.[12][13][15]

The most common side effects include hypersensitivity (allergic) reactions and infusion-related reactions.[10]

Although Sotrovimab was used world-wide against SARS-CoV-2, including in the United States under an FDA emergency use authorization (EUA), the FDA canceled the EUA in April 2022 due to lack of efficacy against the Omicron variant. [16]

  1. ^ a b "Xevudy". Therapeutic Goods Administration (TGA). 20 August 2021. Archived from the original on 18 September 2021.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  3. ^ Cite error: The named reference TGA provisional approval was invoked but never defined (see the help page).
  4. ^ "COVID-19 treatment: GlaxoSmithKline Australia Pty Ltd, sotrovimab (Xevudy)". Therapeutic Goods Administration (TGA). 20 August 2021. Archived from the original on 23 October 2021. Retrieved 22 October 2021.
  5. ^ "Summary Basis of Decision (SBD) for Sotrovimab". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  6. ^ "Sotrovimab (sotrovimab)". Health Canada. 30 July 2021. Archived from the original on 1 June 2022. Retrieved 31 May 2022.
  7. ^ Cite error: The named reference Xevudy CMA was invoked but never defined (see the help page).
  8. ^ "Sotrovimab injection, solution, concentrate". DailyMed. Archived from the original on 7 July 2021. Retrieved 15 June 2021.
  9. ^ "FDA updates Sotrovimab emergency use authorization". U.S. Food and Drug Administration (FDA). 25 February 2022. Archived from the original on 28 March 2022. Retrieved 27 February 2022.
  10. ^ a b c "Xevudy EPAR". European Medicines Agency (EMA). 15 December 2021. Archived from the original on 18 December 2021. Retrieved 17 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  12. ^ a b c "EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19". European Medicines Agency (EMA) (Press release). 7 May 2021. Archived from the original on 3 August 2021. Retrieved 21 May 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. ^ a b "EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19". European Medicines Agency (EMA) (Press release). 21 May 2021. Archived from the original on 29 July 2021. Retrieved 21 May 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ^ "GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19". GlaxoSmithKline (Press release). 7 May 2021. Archived from the original on 22 May 2021. Retrieved 21 May 2021.
  15. ^ "EMA starts review of VIR-7831 for treating patients with COVID-19". European Medicines Agency (EMA) (Press release). 15 April 2021. Archived from the original on 22 May 2021. Retrieved 21 May 2021.
  16. ^ Cite error: The named reference FDA 20220405 was invoked but never defined (see the help page).