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15973 details
Primary information
ID15973
Therapeutic IDTh1658
Protein NameImdevimab
Sequence>Th1658_Imdevimab QVQLVESGGGVVQPGRSLRLSCAASGFTFSNYAMYWVRQAPGKGLEWVAVISYDGSNKYYADSVKGRFTISRDNSKNTLYLQMNSLRTEDTAVYYCASGSDYGDYLLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeNA
DescriptionImdevimab is a monoclonal antibody combined with [casirivimab] in Regeneron's antibody cocktail known as REGEN-COV2 for the treatment of COVID-19.[L23539] 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.[A224429] These antibodies have been formulated to bind to multiple locations on the SARS-COV-2 spike protein, preventing viral escape.[A221495] 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.[L23524] In November 2021, the same indication was approved by the EMA.[L39130,L39135] Full safety and efficacy data on imdevimab are not yet available, and further evaluation of this investigational therapy will continue.[L23529,L23539,L14303]
Indication/DiseaseAccording 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.[L23524,L23534,L39135] 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.[L23534,L23539] **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.[L23524,L23534]
PharmacodynamicsCasirivimab and imdevimab work to neutralize the spike protein of SARS-CoV-2.[L23524] 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.[L23539]
Mechanism of ActionImdevimab 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.[A224424,A224434,L23529] Together with casirivimab, imdevimab neutralizes the spike protein of SARS-CoV-2.[L23529]
ToxicityThere 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.[L39135]
MetabolismNA
AbsorptionNA
NA
ClearanceNA
CategoriesAntibodies
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetSpike glycoprotein
Brand NameCasirivimab With Imdevimab
CompanyRegeneron Pharmaceuticals, Inc.
Brand DescriptionRegeneron Pharmaceuticals, Inc.
Prescribed ForIntravenous
Chemical NameNA
FormulationNA
Physical Appearance hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe dizziness, rash, and itching
Route of AdministrationRegen-Cov is a prescription medicine used to treat the symptoms of COVID-19 (EUA). Regen-Cov may be used alone or with other medications.
Recommended Dosagehives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe dizziness, rash, and itching
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA