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REGEN-COV (casirivimab and imdevimab) should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.","Geriatric use":"Of the 4,567 subjects with SARS-CoV-2 infection randomized in Trial COV-2067, 14% were 65 years or older, and 4% were 75 years of age or older.","Paediatric use":"REGEN-COV is not authorized for use in pediatric patients under 12 years of age or weighing less than 40 kg. The safety and effectiveness of casirivimab and imdevimab are being assessed in pediatric and adolescent patients in an ongoing clinical trial."}},"trials":[],"aliases":[],"company":"Regeneron Pharmaceuticals, Inc.","patents":[],"pricing":[],"allNames":["imdevimab","REGN10987"],"offLabel":[],"synonyms":["imdevimab","REGN10987"],"timeline":[{"date":"2020-11-21","type":"positive","source":"DrugCentral","milestone":"FDA approval (Regeneron Pharmaceuticals, Inc.)"},{"date":"2021-07-19","type":"positive","source":"DrugCentral","milestone":"PMDA approval (CHUGAI PHARMACEUTICAL Co., Ltd)"},{"date":"2021-11-12","type":"positive","source":"DrugCentral","milestone":"EMA approval (Roche Registration Gmbh)"}],"approvals":[{"date":"2020-11-21","orphan":false,"company":"Regeneron Pharmaceuticals, Inc.","regulator":"FDA"},{"date":"2021-07-19","orphan":false,"company":"CHUGAI PHARMACEUTICAL Co., Ltd","regulator":"PMDA"},{"date":"2021-11-12","orphan":false,"company":"ROCHE REGISTRATION GMBH","regulator":"EMA"}],"ecosystem":[{"indication":"COVID-19","otherDrugs":[{"name":"bamlanivimab","slug":"bamlanivimab","company":"Eli Lilly and Company"},{"name":"casirivimab","slug":"casirivimab","company":"Regeneron Pharmaceuticals, Inc."},{"name":"etesevimab","slug":"etesevimab","company":"Eli Lilly and Company"},{"name":"nirmatrelvir","slug":"nirmatrelvir","company":"Pfizer, Inc."}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Monoclonal Antibody","explanation":"Casirivimab (IgG1) and imdevimab (IgG1) are two recombinant human mAbs which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2 with dissociation constants KD 45.8 pM and 46.7 pM, respectively. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human ACE2 receptor with IC50 values of 56.4 pM, 165 pM and 81.8 pM, respectively and prevents viral attachment to host cells [see Microbiology/Resistance Information (15) ].","oneSentence":"IMDEVIMAB works by binding to the SARS-CoV-2 virus to prevent it from entering host cells.","technicalDetail":"IMDEVIMAB is a monoclonal antibody that binds to the SARS-CoV-2 spike protein, preventing the virus from fusing with host cells and initiating infection."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-11-21, Regeneron Pharmaceuticals, Inc.)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5456","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=IMDEVIMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IMDEVIMAB","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T13:55:39.903675","biosimilars":[],"competitors":[{"drugName":"palivizumab","drugSlug":"palivizumab","fdaApproval":"1998-06-19","relationship":"same-class"},{"drugName":"ansuvimab","drugSlug":"ansuvimab","fdaApproval":"2020-12-21","relationship":"same-class"},{"drugName":"casirivimab","drugSlug":"casirivimab","fdaApproval":"2020-11-21","relationship":"same-class"},{"drugName":"nirsevimab","drugSlug":"nirsevimab","fdaApproval":"2023-07-17","relationship":"same-class"}],"genericName":"imdevimab","indications":{"approved":[{"name":"COVID-19","source":"DrugCentral","snomedId":840539006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"palivizumab","brandName":"palivizumab","genericName":"palivizumab","approvalYear":"1998","relationship":"same-class"},{"drugId":"ansuvimab","brandName":"ansuvimab","genericName":"ansuvimab","approvalYear":"2020","relationship":"same-class"},{"drugId":"casirivimab","brandName":"casirivimab","genericName":"casirivimab","approvalYear":"2020","relationship":"same-class"},{"drugId":"nirsevimab","brandName":"nirsevimab","genericName":"nirsevimab","approvalYear":"2023","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05041907","phase":"PHASE2","title":"Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2021-09-30","conditions":["COVID-19"],"enrollment":3800,"completionDate":"2027-01"},{"nctId":"NCT05195060","phase":"","title":"TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - 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