Imdevimab
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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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to prevent Coronavirus disease 2019 (covid‑19) Combination Product in combination with: Casirivimab (DB15941) •••••••••••• ••••••••••• ••••• •••••• •• •• •• •••• ••••••••• Used in combination to treat Coronavirus disease 2019 (covid‑19) Combination Product in combination with: Casirivimab (DB15941) •••••••••••• ••••••••••• ••••• •••• •••• ••• ••••••••••• •• •••••• •••••••• •••••• •• •• •• ••••• •••• •• •••••••• •••••••• ••••••••• - 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
Target Actions Organism ASpike glycoprotein binderSARS-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
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Imdevimab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Imdevimab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Imdevimab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Imdevimab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Imdevimab. - Food Interactions
- Not Available
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Imdevimab Injection, solution, concentrate 1332 mg/11.1mL Intravenous Regeneron Pharmaceuticals, Inc. 2020-11-21 Not applicable US Imdevimab Injection, solution, concentrate 300 mg/2.5mL Intravenous Regeneron Pharmaceuticals, Inc. 2020-11-21 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Casirivimab and Imdevimab Imdevimab (300 mg / 2.5 mL) + Casirivimab (300 mg / 2.5 mL) Solution Intravenous Hoffmann La Roche Not applicable Not applicable Canada Casirivimab and Imdevimab Imdevimab (1332 mg / 11.1 mL) + Casirivimab (1332 mg / 11.1 mL) Solution Intravenous Hoffmann La Roche 2021-07-29 Not applicable Canada Ronapreve Imdevimab (120 mg/ml) + Casirivimab (120 mg/ml) Injection, solution Intravenous; Subcutaneous Roche Registration Gmb H 2021-11-22 Not applicable EU Ronapreve Imdevimab (300 mg) + Casirivimab (300 mg) Injection, solution Intravenous; Subcutaneous Roche Registration Gmb H 2021-11-22 Not applicable EU - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Casirivimab With Imdevimab Imdevimab (1332 mg/11.1mL) + Casirivimab (1332 mg/11.1mL) Injection, solution, concentrate; Kit Intravenous Regeneron Pharmaceuticals, Inc. 2021-02-07 Not applicable US Casirivimab With Imdevimab Imdevimab (300 mg/2.5mL) + Casirivimab (300 mg/2.5mL) Injection, solution, concentrate; Kit Intravenous Regeneron Pharmaceuticals, Inc. 2021-02-07 Not applicable US Imdevimab Imdevimab (1332 mg/11.1mL) Injection, solution, concentrate Intravenous Regeneron Pharmaceuticals, Inc. 2020-11-21 Not applicable US Imdevimab Imdevimab (300 mg/2.5mL) Injection, solution, concentrate Intravenous Regeneron Pharmaceuticals, Inc. 2020-11-21 Not applicable US Regen-cov Imdevimab (300 mg/2.5mL) + Casirivimab (1332 mg/11.1mL) Injection Intravenous Regeneron Pharmaceuticals, Inc. 2021-02-07 Not applicable US
Categories
- ATC Codes
- J06BD07 — Casirivimab and imdevimab
- 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
- 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]
- 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]
- 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]
- 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]
- FDA Letter: EUA for Regeneron's casirivimab and imdevimab [Link]
- FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 [Link]
- FDA Fact Sheet: Regeneron EUA HCP Fact Sheet [Link]
- Regeneron: Casirivimab and imdevimab [Link]
- Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 [Link]
- EMA COVID-19 News: EMA recommends authorisation of two monoclonal antibody medicines [Link]
- EMA Summary of Product Characteristics: RONAPREVE (casirivimab and imdevimab) intravenous or subcutaneous injection [Link]
- External Links
- 2465249
- Wikipedia
- Casirivimab/imdevimab
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Not Available Coronavirus Disease 2019 (COVID‑19) / Critically Ill Patients / Interleukin 6 / Outcome, Fatal / Tocilizumab 1 somestatus stop reason just information to hide Not Available No Longer Available Not Available Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide Not Available Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) 2 somestatus stop reason just information to hide Not Available Unknown Status Not Available Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide 4 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Intravenous Injection, solution, concentrate; kit Intravenous Injection, solution, concentrate Intravenous 1332 mg/11.1mL Injection, solution, concentrate Intravenous 300 mg/2.5mL Injection Intravenous Injection, solution, concentrate Intravenous Injection, solution Intravenous; Subcutaneous - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Targets
- 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. The major receptor is host ACE2 (PubMed:32142651, PubMed:32155444, PubMed:33607086). When S2/S2' has been cleaved, binding to the receptor triggers direct fusion at the cell membrane (PubMed:34561887). When S2/S2' has not been cleaved, binding to the receptor results in internalization of the virus by endocytosis leading to fusion of the virion membrane with the host endosomal membrane (PubMed:32075877, PubMed:32221306). Alternatively, may use NRP1/NRP2 (PubMed:33082294, PubMed:33082293) and integrin as entry receptors (PubMed:35150743). The use of NRP1/NRP2 receptors may explain the tropism of the virus in human olfactory epithelial cells, which express these molecules at high levels but ACE2 at low levels (PubMed:33082293). The stalk domain of S contains three hinges, giving the head unexpected orientational freedom (PubMed:32817270).
- Specific Function
- host cell surface receptor binding
- Gene Name
- S
- Uniprot ID
- P0DTC2
- Uniprot Name
- Spike glycoprotein
- Molecular Weight
- 141177.29 Da
References
Drug created at November 25, 2020 18:40 / Updated at December 04, 2021 06:47