Sotrovimab

Identification

Summary

Sotrovimab is a monoclonal antibody for the treatment of mild-to-moderate COVID-19 in patients at increased risk for death or hospitalization.

Generic Name

Sotrovimab

DrugBank Accession Number

DB16355

Background

Sotrovimab (VIR-7831), also known as GSK4182136, is a monoclonal antibody that can neutralize the SARS-CoV-2 virus.⁷ Sotrovimab was initially been granted emergency use authorization (EUA) to treat mild-to-moderate COVID-19 on May 26, 2021, based on interim results from a clinical trial, where sotrovimab was found to reduce the risk of death or hospitalization in high-risk adults with COVID-19 in the outpatient setting.^5,6,7 However, in April 2022, the FDA removed the EUA for sotrovimab due to the rising COVID-19 cases caused by the Omicron BA.2 sub-variant, where the drug is ineffective.¹¹

Sotrovimab was granted marketing authorization in the European Union in December 2021 under the brand name Xevudy.^9,10

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Protein Based Therapies
Monoclonal antibody (mAb)

Protein Chemical Formula

Not Available

Protein Average Weight

149000.0 Da

Sequences

Not Available

Synonyms

Sotrovimab

External IDs

GSK-4182136
GSK4182136
VIR-7831
VIR7831

Pharmacology

Indication

In Europe, sotrovimab is indicated for the treatment of COVID-19 in patients ≥12 years old and weighing ≥40kg who do not require supplemental oxygen and are at high risk of progressing to severe disease.¹⁰

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Associated Conditions

Coronavirus Disease 2019 (COVID‑19)

Contraindications & Blackbox Warnings

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Pharmacodynamics

Sotrovimab is a monoclonal antibody that treats mild-to-moderate COVID-19 by binding to and neutralizing the spike protein of SARS-CoV-2.^3,7

Mechanism of action

Sotrovimab is a recombinant human IgG1κ monoclonal antibody that acts by binding to a conserved epitope located on the spike protein receptor-binding domain of SARS-CoV-2, the virus causing COVID-19. The epitope is highly conserved, discouraging the development of viral resistance to the antibody.⁴ This prevents the spike protein mediated binding of SARS-CoV-2 and entry into human cells.² Sotrovimab does not compete with human ACE2 receptor binding and inhibits an undefined step that occurs after viral attachment and before the fusion of the viral and cell membranes. The Fc component of sotrovimab includes M428L and N434S amino acid substitutions (LS modification) that result in a longer half-life.⁶

Target	Actions	Organism
USpike glycoprotein	binder	SARS-CoV-2

Absorption

A non-compartmental analysis determined that the mean Cmax after a 1 hour IV infusion of sotrovimab was 137 µg/mL and the mean Day 29 concentration was 34 µg/mL.⁶

Volume of distribution

Sotrovimab is an Fc-enhanced human immunoglobulin G (IgG), and therefore has the potential for placental transfer.⁶

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Not Available

Half-life

This antibody has undergone modifications for a potentially extended half-life and enhanced lung bioavailability.⁴ The half-life of sotrovimab is longer than Fc-unmodified IgG due to the LS modification, however, specific values are not available in the literature.⁶

Clearance

Not Available

Adverse Effects

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Toxicity

There are currently no data available regarding an overdose with sotrovimab, and LD50 information is not available. If an overdose occurs, provide symptomatic and supportive treatment as required.⁶

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Interactions

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Drug	Interaction
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Abciximab	The risk or severity of adverse effects can be increased when Abciximab is combined with Sotrovimab.
Adalimumab	The risk or severity of adverse effects can be increased when Adalimumab is combined with Sotrovimab.
Adenovirus type 7 vaccine live	The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Sotrovimab.
Aducanumab	The risk or severity of adverse effects can be increased when Aducanumab is combined with Sotrovimab.
Alemtuzumab	The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Sotrovimab.
Alirocumab	The risk or severity of adverse effects can be increased when Alirocumab is combined with Sotrovimab.
Amivantamab	The risk or severity of adverse effects can be increased when Sotrovimab is combined with Amivantamab.
Anifrolumab	The risk or severity of adverse effects can be increased when Anifrolumab is combined with Sotrovimab.
Ansuvimab	The risk or severity of adverse effects can be increased when Sotrovimab is combined with Ansuvimab.
Anthrax immune globulin human	The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Sotrovimab.

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Food Interactions

No interactions found.

Products

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Sotrovimab	Injection, solution, concentrate	62.5 mg/1mL	Intravenous	GlaxoSmithKline LLC	2021-05-26	Not applicable
Sotrovimab for Injection	Solution	500 mg / 8 mL	Intravenous	Glaxosmithkline Inc	2021-10-08	Not applicable
Xevudy	Injection, solution, concentrate	500 mg/8ml	Intravenous	Glaxo Smith Kline Trading Services	2022-01-21	Not applicable

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Sotrovimab	Sotrovimab (62.5 mg/1mL)	Injection, solution, concentrate	Intravenous	GlaxoSmithKline LLC	2021-05-26	Not applicable

Chemical Identifiers

UNII: 1MTK0BPN8V
CAS number: 2423014-07-5

References

General References

Ning L, Abagna HB, Jiang Q, Liu S, Huang J: Development and application of therapeutic antibodies against COVID-19. Int J Biol Sci. 2021 Apr 10;17(6):1486-1496. doi: 10.7150/ijbs.59149. eCollection 2021. [Article]
Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149. [Article]
Owji H, Negahdaripour M, Hajighahramani N: Immunotherapeutic approaches to curtail COVID-19. Int Immunopharmacol. 2020 Nov;88:106924. doi: 10.1016/j.intimp.2020.106924. Epub 2020 Aug 21. [Article]
GSK: Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19 [Link]
FDA Emergency Use Authorization Letter: Sotrovimab [Link]
FDA: Sotrovimab fact sheet for healthcare providers [Link]
GlaxoSmithKline: 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 paediatric patients [Link]
Clinicaltrials.gov: VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE) [Link]
BioSpace: Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19 [Link]
EMA Summary of Product Characteristics: Xevudy (sotrovimab) concentrate for solution for infusion [Link]
FDA Drug Safety and Availability: FDA updates Sotrovimab emergency use authorization [Link]

External Links

RxNav: 2550731
Wikipedia: Sotrovimab

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
4	Completed	Other	Coronavirus Disease 2019 (COVID‑19)	1
4	Recruiting	Treatment	Coronavirus Disease 2019 (COVID‑19)	1
4	Terminated	Treatment	Coronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections	1
3	Active Not Recruiting	Treatment	Coronavirus Disease 2019 (COVID‑19)	2
3	Recruiting	Treatment	Coronavirus Disease 2019 (COVID‑19)	1
3	Terminated	Treatment	Coronavirus Disease 2019 (COVID‑19)	1
2	Active Not Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19)	1
2	Completed	Treatment	Coronavirus Disease 2019 (COVID‑19)	2
2	Recruiting	Treatment	Coronavirus Disease 2019 (COVID‑19)	2
2, 3	Completed	Treatment	Coronavirus Disease 2019 (COVID‑19)	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection, solution, concentrate	Intravenous	62.5 mg/1mL
Solution	Intravenous	500 mg / 8 mL
Injection, solution, concentrate	Intravenous	500 mg/8ml

Prices

Not Available

Patents

Not Available

Properties

State: Liquid
Experimental Properties: Not Available

Targets

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Details1. Spike glycoprotein

Kind: Protein
Organism: SARS-CoV-2
Pharmacological action: Unknown
Actions: Binder

General Function: Spike protein S1 attaches the virion to the cell membrane by interacting with host receptor, initiating the infection. Binding to human ACE2 receptor and internalization of the virus into the endosomes of the host cell induces conformational changes in the Spike glycoprotein (PubMed:32142651, PubMed:32075877, PubMed:32155444). Uses also human TMPRSS2 for priming in human lung cells which is an essential step for viral entry (PubMed:32142651). Can be alternatively processed by host furin (PubMed:32362314). Proteolysis by cathepsin CTSL may unmask the fusion peptide of S2 and activate membranes fusion within endosomes.
Specific Function: Host cell surface receptor binding
Gene Name: S
Uniprot ID: P0DTC2
Uniprot Name: Spike glycoprotein
Molecular Weight: 141177.29 Da

References

Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149. [Article]
GlaxoSmithKline: 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 paediatric patients [Link]

Drug created at December 16, 2020 17:22 / Updated at June 03, 2022 07:24

Sotrovimab

Identification

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Pharmacoeconomics

Properties

Targets

References