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 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
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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
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofCoronavirus 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

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
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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.
DrugInteraction
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interactions in your software
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Sotrovimab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Sotrovimab.
Adenovirus type 7 vaccine liveThe therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Sotrovimab.
AducanumabThe risk or severity of adverse effects can be increased when Aducanumab is combined with Sotrovimab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Sotrovimab.
Food Interactions
No interactions found.

Products

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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 Inc2021-10-08Not applicableCanada flag
XevudyInjection, solution, concentrate500 mg/8mlIntravenousGlaxo Smith Kline Trading Services2022-01-21Not applicableEU flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
SotrovimabSotrovimab (62.5 mg/1mL)Injection, solution, concentrateIntravenousGlaxoSmithKline LLC2021-05-26Not applicableUS flag

Categories

ATC Codes
J06BD05 — Sotrovimab
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]
  9. BioSpace: Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19 [Link]
  10. EMA Summary of Product Characteristics: Xevudy (sotrovimab) concentrate for solution for infusion [Link]
  11. FDA Drug Safety and Availability: FDA updates Sotrovimab emergency use authorization [Link]
RxNav
2550731
Wikipedia
Sotrovimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
4TerminatedOtherCoronavirus Disease 2019 (COVID‑19)1
4TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections1
3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)3
3RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Severe Acute Respiratory Syndrome (SARS)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solution, concentrateIntravenous62.5 mg/1mL
SolutionIntravenous500 mg / 8 mL
Injection, solution, concentrateIntravenous500 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
  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 at December 16, 2020 17:22 / Updated at June 03, 2022 07:24