Identification

Summary

Imdevimab is part of an investigational recombinant monoclonal antibody cocktail used to treat mild to moderate COVID-19.

Generic Name
Imdevimab
DrugBank Accession Number
DB15940
Background

Imdevimab is a monoclonal antibody combined with casirivimab in Regeneron's antibody cocktail known as REGEN-COV2 for the treatment of COVID-19.8 This drug is a combination of antibodies derived from humanized VelocImmune® mice in addition to blood samples from patients who have recovered from COVID-19.2 These antibodies have been formulated to bind to multiple locations on the SARS-COV-2 spike protein, preventing viral escape.3

On November 21, 2020, the FDA authorized emergency approval of REGN-COV2 to treat mild to moderate COVID-19 in patients aged 12 years and older. Casirivimab and imdevimab are investigational recombinant human IgG1 monoclonal antibodies that, at this time, are not officially approved by the FDA. They are reserved for Emergency Use Authorization (EUA) only.5 In November 2021, the same indication was approved by the EMA.10,11

Full safety and efficacy data on imdevimab are not yet available, and further evaluation of this investigational therapy will continue.6,8,9

Type
Biotech
Groups
Approved, Experimental
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Imdevimab
External IDs
  • REGN 10987
  • REGN-10987
  • REGN10987

Pharmacology

Indication

According to the Emergency Use Authorization (EUA) by the FDA and EMA, indevimab is used only with casirivimab to prevent COVID-19 and treat mild to moderate COVID-19 from laboratory-confirmed SARS-CoV-2 infection in patients aged 12 years of age and older who weigh at least 40 kg. Treatment is reserved for patients who are at high risk for progressing to require hospitalization or severe COVID-19.5,7,11

This combination may only be administered by intravenous infusion in healthcare settings with immediate access to treatment for infusion reactions and anaphylaxis, and the ability to activate the emergency medical system (EMS), as required.7,8

Limitations of use

Imdevimab and casirivimab are not for use in patients currently hospitalized due to COVID-19, patients requiring oxygen therapy due to COVID-19, patients requiring increases in baseline oxygen flow rate from COVID-19, or patients on oxygen therapy for non-COVID-19 related morbidity.5,7

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Casirivimab and imdevimab work to neutralize the spike protein of SARS-CoV-2.5 In a clinical trial, casirivimab and imdevimab, when given together, reduced COVID-19-related hospitalization or emergency room visits in patients diagnosed with COVID-19 who were at high risk for disease progression within 28 days after treatment. No benefit has been shown in patients already hospitalized due to COVID-19 receiving this combination.8

Mechanism of action

Imdevimab is a recombinant human IgG1 monoclonal antibody targeting the receptor binding domain of the spike protein of SARS-CoV-2; a protein playing an important role in viral attachment, fusion, and entry into the target cell by binding to the ACE2 receptor.1,4,6 Together with casirivimab, imdevimab neutralizes the spike protein of SARS-CoV-2.6

TargetActionsOrganism
ASpike glycoprotein
binder
SARS-CoV-2
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

There is limited information on overdose. Up to 4000 mg, which is approximately seven times the recommended dose of the drug, was administered in clinical trials. There is no known specific antidote for imdevimab overdose so treatment of overdose should involve general supportive measures.11

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
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Imdevimab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Imdevimab.
AducanumabThe risk or severity of adverse effects can be increased when Aducanumab is combined with Imdevimab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Imdevimab.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Imdevimab.
AmivantamabThe risk or severity of adverse effects can be increased when Imdevimab is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Anifrolumab is combined with Imdevimab.
AnsuvimabThe risk or severity of adverse effects can be increased when Imdevimab is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Imdevimab.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Imdevimab.
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Food Interactions
Not Available

Products

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dosage, form, labeller, route of administration, and marketing period.
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ImdevimabInjection, solution, concentrate1332 mg/11.1mLIntravenousRegeneron Pharmaceuticals, Inc.2020-11-21Not applicableUS flag
ImdevimabInjection, solution, concentrate300 mg/2.5mLIntravenousRegeneron Pharmaceuticals, Inc.2020-11-21Not applicableUS flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Casirivimab and ImdevimabImdevimab (300 mg / 2.5 mL) + Casirivimab (300 mg / 2.5 mL)SolutionIntravenousHoffmann La RocheNot applicableNot applicableCanada flag
Casirivimab and ImdevimabImdevimab (1332 mg / 11.1 mL) + Casirivimab (1332 mg / 11.1 mL)SolutionIntravenousHoffmann La Roche2021-07-29Not applicableCanada flag
RonapreveImdevimab (120 mg/ml) + Casirivimab (120 mg/ml)Injection, solutionIntravenous; SubcutaneousRoche Registration Gmb H2021-11-22Not applicableEU flag
RonapreveImdevimab (300 mg) + Casirivimab (300 mg)Injection, solutionIntravenous; SubcutaneousRoche Registration Gmb H2021-11-22Not applicableEU flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Casirivimab With ImdevimabImdevimab (1332 mg/11.1mL) + Casirivimab (1332 mg/11.1mL)Injection, solution, concentrate; KitIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not applicableUS flag
Casirivimab With ImdevimabImdevimab (300 mg/2.5mL) + Casirivimab (300 mg/2.5mL)Injection, solution, concentrate; KitIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not applicableUS flag
ImdevimabImdevimab (1332 mg/11.1mL)Injection, solution, concentrateIntravenousRegeneron Pharmaceuticals, Inc.2020-11-21Not applicableUS flag
ImdevimabImdevimab (300 mg/2.5mL)Injection, solution, concentrateIntravenousRegeneron Pharmaceuticals, Inc.2020-11-21Not applicableUS flag
Regen-covImdevimab (300 mg/2.5mL) + Casirivimab (1332 mg/11.1mL)InjectionIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not applicableUS flag
Regen-covImdevimab (600 mg/10mL) + Casirivimab (600 mg/10mL)Injection, solution, concentrateIntravenousRegeneron Pharmaceuticals, Inc.2021-06-03Not applicableUS flag
Regen-covImdevimab (300 mg/2.5mL) + Casirivimab (300 mg/2.5mL)InjectionIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not applicableUS flag
Regen-covImdevimab (1332 mg/11.1mL) + Casirivimab (300 mg/2.5mL)InjectionIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not applicableUS flag
Regen-covImdevimab (1332 mg/11.1mL) + Casirivimab (1332 mg/11.1mL)InjectionIntravenousRegeneron Pharmaceuticals, Inc.2021-02-07Not 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
2Z3DQD2JHM
CAS number
2415933-40-1

References

Synthesis Reference

Hansen J, Baum A, Pascal KE, et al. Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science. 2020;369(6506):1010-1014. doi:10.1126/science.abd0827

General References
  1. Baum A, Fulton BO, Wloga E, Copin R, Pascal KE, Russo V, Giordano S, Lanza K, Negron N, Ni M, Wei Y, Atwal GS, Murphy AJ, Stahl N, Yancopoulos GD, Kyratsous CA: Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. Science. 2020 Aug 21;369(6506):1014-1018. doi: 10.1126/science.abd0831. Epub 2020 Jun 15. [Article]
  2. Hansen J, Baum A, Pascal KE, Russo V, Giordano S, Wloga E, Fulton BO, Yan Y, Koon K, Patel K, Chung KM, Hermann A, Ullman E, Cruz J, Rafique A, Huang T, Fairhurst J, Libertiny C, Malbec M, Lee WY, Welsh R, Farr G, Pennington S, Deshpande D, Cheng J, Watty A, Bouffard P, Babb R, Levenkova N, Chen C, Zhang B, Romero Hernandez A, Saotome K, Zhou Y, Franklin M, Sivapalasingam S, Lye DC, Weston S, Logue J, Haupt R, Frieman M, Chen G, Olson W, Murphy AJ, Stahl N, Yancopoulos GD, Kyratsous CA: Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science. 2020 Aug 21;369(6506):1010-1014. doi: 10.1126/science.abd0827. Epub 2020 Jun 15. [Article]
  3. Matthews DB: A cocktail of antibodies for COVID-19 therapy. Nat Rev Immunol. 2020 Oct;20(10):591. doi: 10.1038/s41577-020-00431-9. [Article]
  4. Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L: Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19. [Article]
  5. FDA Letter: EUA for Regeneron's casirivimab and imdevimab [Link]
  6. FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 [Link]
  7. FDA Fact Sheet: Regeneron EUA HCP Fact Sheet [Link]
  8. Regeneron: Casirivimab and imdevimab [Link]
  9. Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 [Link]
  10. EMA COVID-19 News: EMA recommends authorisation of two monoclonal antibody medicines [Link]
  11. EMA Summary of Product Characteristics: RONAPREVE (casirivimab and imdevimab) intravenous or subcutaneous injection [Link]
RxNav
2465249
Wikipedia
Casirivimab/imdevimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedOtherCoronavirus Disease 2019 (COVID‑19)1
4CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19) / Healthy Subjects (HS)1
3TerminatedPreventionCoronavirus Disease 2019 (COVID‑19) / Immunocompromised1
3TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19)2
2Active Not RecruitingTreatmentChronic Stable Illness / Coronavirus Disease 2019 (COVID‑19) / Healthy Subjects (HS)1
2CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
2RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)2
2TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19)1
2, 3Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionIntravenous
Injection, solution, concentrate; kitIntravenous
Injection, solution, concentrateIntravenous1332 mg/11.1mL
Injection, solution, concentrateIntravenous300 mg/2.5mL
InjectionIntravenous
Injection, solution, concentrateIntravenous
Injection, solutionIntravenous; Subcutaneous
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Targets

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Kind
Protein
Organism
SARS-CoV-2
Pharmacological action
Yes
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. Matthews DB: A cocktail of antibodies for COVID-19 therapy. Nat Rev Immunol. 2020 Oct;20(10):591. doi: 10.1038/s41577-020-00431-9. [Article]
  2. Regeneron: Casirivimab and imdevimab [Link]

Drug created at November 25, 2020 18:40 / Updated at December 04, 2021 06:47