Sotrovimab

From Wikipedia, the free encyclopedia

Sotrovimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Trade namesXevudy
Other namesVIR-7831, GSK4182136
AHFS/Drugs.comMultum Consumer Information
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
  • AU: S4 (Prescription only) [1][2][3]
  • UK: POM (Prescription only) [4]
  • US: ℞-only via emergency use authorization [5]
  • EU: Rx-only [6]
Identifiers
CAS Number
  • 2423014-07-5
IUPHAR/BPS
DrugBank
UNII
KEGG

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.[6][7][8] It is under development by GlaxoSmithKline and Vir Biotechnology, Inc.[7][9] Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.[7][8][10]

The most common side effects include hypersensitivity (allergic) reactions and infusion-related reactions.[6]

Medical uses[]

In the European Union, sotrovimab is indicated for the treatment of COVID-19 in people aged twelve years of age and older and weighing at least 40 kilograms (88 lb) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.[6]

Development and mechanism of action[]

Sotrovimab has been engineered to possess an Fc LS mutation (M428L/N434S) that confers enhanced binding to the neonatal Fc receptor[11] resulting in an extended half-life and potentially enhanced drug distribution to the lungs.[12]

Sotrovimab has demonstrated activity via two antiviral mechanisms in vitro, antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).[12]

Clinical efficacy[]

The pivotal COMET-ICE study is an ongoing, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of sotrovimab in adults with confirmed COVID-19 (mild, early disease with less than five days of symptoms) at risk of disease progression.

An interim analysis of this study reported that sotrovimab reduced the risk of hospitalization for more than 24 hours or death by 85% compared with placebo. Overall 1% of people receiving sotrovimab died or required hospitalization for more than 24 hours compared to 7% of people treated with placebo.[8] The study is ongoing and preliminary results have been published in the New England Journal of Medicine.[13]

Society and culture[]

Economics[]

In 2021, the United States government agreed to purchase 1.5 million doses of the drug at $2,100 per dose.[14]

Legal status[]

On 21 May 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) completed its review on the use of sotrovimab for the treatment of COVID‑19. It concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged twelve years and above and weighing at least 40 kilograms (88 lb)) who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19.[8] On 16 December 2021, the CHMP recommended authorizing sotrovimab for use in the EU[6][15] and authorization was granted the next day.[6][16]

On 26 May 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sotrovimab for the treatment of mild-to-moderate COVID-19 in people aged aged twelve years and above weighing at least 40 kilograms (88 lb) 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.[17][18][19][20]

In August 2021, sotrovimab was granted provisional approval for the treatment of COVID-19 in Australia.[2]

On 27 September 2021, sotrovimab was granted special exception authorization in Japan.[21]

In December 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom approved sotrovimab for use in people aged twelve years of age and over who weigh more than 40 kilograms (88 lb).[22][23][4]

Research[]

Sotrovimab is being evaluated in the following clinical trials:[12]

  • Clinical trial number NCT04545060 for "COMET-ICE" at ClinicalTrials.gov
  • Clinical trial number NCT04779879 for "COMET-PEAK" at ClinicalTrials.gov
  • Clinical trial number NCT04501978 for "ACTIV-3-TICO" at ClinicalTrials.gov
  • Clinical trial number NCT04634409 for "BLAZE-4" at ClinicalTrials.gov

References[]

  1. ^ a b "Xevudy". Therapeutic Goods Administration (TGA). 20 August 2021. Retrieved 17 September 2021.
  2. ^ a b "TGA provisionally approves GlaxoSmithKline's COVID-19 treatment: sotrovimab (Xevudy)". Therapeutic Goods Administration (TGA) (Press release). 20 August 2021. Retrieved 4 September 2021.
  3. ^ "COVID-19 treatment: GlaxoSmithKline Australia Pty Ltd, sotrovimab (Xevudy)". Therapeutic Goods Administration (TGA). 20 August 2021. Retrieved 22 October 2021.
  4. ^ a b "Regulatory approval of Xevudy (sotrovimab)". Medicines and Healthcare products Regulatory Agency (MHRA). 2 December 2021. Retrieved 24 December 2021.
  5. ^ "Sotrovimab injection, solution, concentrate". DailyMed. Retrieved 15 June 2021.
  6. ^ a b c d e f "Xevudy EPAR". European Medicines Agency (EMA). 15 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.
  7. ^ a b c "EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19". European Medicines Agency (EMA) (Press release). 7 May 2021. Retrieved 21 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ a b c d "EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19". European Medicines Agency (EMA) (Press release). 21 May 2021. Retrieved 21 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ "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. Retrieved 21 May 2021.
  10. ^ "EMA starts review of VIR-7831 for treating patients with COVID-19". European Medicines Agency (EMA) (Press release). 15 April 2021. Retrieved 21 May 2021.
  11. ^ Saunders KO (2019). "Conceptual Approaches to Modulating Antibody Effector Functions and Circulation Half-Life". Frontiers in Immunology. 10: 1296. doi:10.3389/fimmu.2019.01296. PMC 6568213. PMID 31231397.
  12. ^ a b c "Assessment Report: Use of sotrovimab for the treatment of COVID-19" (PDF). European Medicines Agency. May 2021.
  13. ^ Gupta, Anil; Gonzalez-Rojas, Yaneicy; Juarez, Erick; Crespo Casal, Manuel; Moya, Jaynier; Falci, Diego R.; Sarkis, Elias; Solis, Joel; Zheng, Hanzhe; Scott, Nicola; Cathcart, Andrea L.; Hebner, Christy M.; Sager, Jennifer; Mogalian, Erik; Tipple, Craig; Peppercorn, Amanda; Alexander, Elizabeth; Pang, Phillip S.; Free, Almena; Brinson, Cynthia; Aldinger, Melissa; Shapiro, Adrienne E.; COMET-ICE Investigators (18 November 2021). "Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab". New England Journal of Medicine. 385 (21): 1941–1950. doi:10.1056/NEJMoa2107934. PMID 34706189. S2CID 240074048. Retrieved 28 November 2021.
  14. ^ "After slow start, demand for COVID monoclonal antibodies treatment skyrockets". USA Today. 25 August 2021. Retrieved 18 December 2021.
  15. ^ "COVID-19: EMA recommends authorisation of antibody medicine Xevudy" (Press release). 16 December 2021.
  16. ^ "Xevudy". Union Register of medicinal products. Retrieved 24 December 2021.
  17. ^ "Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19". U.S. Food and Drug Administration (FDA) (Press release). 26 May 2021. Retrieved 26 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  18. ^ "Emergency Use Authorization 100: Sotrovimab". U.S. Food and Drug Administration (FDA). 28 May 2021.
  19. ^ "Fact Sheet for Healthcare Providers Emergency Use Authorization (Eua) of Sotrovimab". U.S. Food and Drug Administration (FDA). 2021.
  20. ^ "Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab". U.S. Food and Drug Administration (FDA). 26 May 2021.
  21. ^ "GSK Received Approval for Monoclonal Antibody, "Xevudy for Intravenous Injection" (generic name: sotrovimab), for the treatment of COVID-19" (PDF) (Press release). 27 September 2021. Retrieved 1 January 2022.
  22. ^ "UK approves another antibody treatment for Covid". BBC News Online. 2 December 2021. Retrieved 2 December 2021.
  23. ^ "MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%". Medicines and Healthcare products Regulatory Agency (MHRA) (Press release). 2 December 2021. Retrieved 24 December 2021.

External links[]


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