NAV

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 with the ability to neutralize the SARS-CoV-2 virus.7 On May 26, 2021 the FDA granted GlaxoSmithKline and Vir Biotechnology emergency use authorization for sotrovimab in the treatment of mild-to-moderate COVID-19. This authorization was based on interim results from a clinical trial, demonstrating that treatment with sotrovimab resulted in an 85% reduction in the risk of death or hospitalization in high-risk adults with COVID-19 in the outpatient setting.5,7 A fact sheet for healthcare providers is currently available.6

Type
Biotech
Groups
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

Sotrovimab is authorized for use under FDA's Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARSCoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.5

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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

TargetActionsOrganism
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
Adverseeffects
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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.
Not Available
Food Interactions
No interactions found.

Products

Products2
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
SotrovimabInjection, solution, concentrate62.5 mg/1mLIntravenousGlaxoSmithKline LLC2021-05-26Not applicableUS flag
Sotrovimab for InjectionSolution500 mg / 8 mLIntravenousGlaxosmithkline IncNot applicableNot applicableCanada flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
SotrovimabSotrovimab (62.5 mg/1mL)Injection, solution, concentrateIntravenousGlaxoSmithKline LLC2021-05-26Not applicableUS flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
Not Available

Chemical Identifiers

UNII
1MTK0BPN8V
CAS number
2423014-07-5

References

General References
  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. FDA Emergency Use Authorization Letter: Sotrovimab [Link]
  6. FDA: Sotrovimab fact sheet for healthcare providers [Link]
  7. 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]
  8. Clinicaltrials.gov: VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE) [Link]
RxNav
2550731
Wikipedia
Sotrovimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections1
3Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
3RecruitingOtherCoronavirus Disease 2019 (COVID‑19)1
3RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
2Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)2
2, 3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
1Active Not RecruitingOtherCoronavirus Disease 2019 (COVID‑19)1
1, 2RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solution, concentrateIntravenous62.5 mg/1mL
SolutionIntravenous500 mg / 8 mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

Drugtargets2
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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
  1. 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]
  2. 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 on December 16, 2020 17:22 / Updated on July 03, 2021 01:49