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| Stem definition | Drug id | CAS RN |
|---|---|---|
| primate origin | 5456 | 2415933-40-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Imdevimab with casirivimab to be administered together is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab(IgG1kappa) and imdevimab (IgG1lambda) 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. 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.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 21, 2020 | FDA | Regeneron Pharmaceuticals, Inc. | |
| July 19, 2021 | PMDA | CHUGAI PHARMACEUTICAL Co., Ltd | |
| Nov. 12, 2021 | EMA | ROCHE REGISTRATION GMBH |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 106.67 | 48.23 | 52 | 535 | 416728 | 90211132 |
| COVID-19 pneumonia | 83.16 | 48.23 | 20 | 567 | 18157 | 90609703 |
| Flushing | 66.68 | 48.23 | 24 | 563 | 88467 | 90539393 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 124.57 | 43.97 | 41 | 495 | 60765 | 42560034 |
| COVID-19 pneumonia | 70.97 | 43.97 | 21 | 515 | 21592 | 42599207 |
| Hypoxia | 50.18 | 43.97 | 22 | 514 | 69764 | 42551035 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 205.98 | 52.51 | 94 | 1122 | 381068 | 110207015 |
| COVID-19 pneumonia | 153.72 | 52.51 | 42 | 1174 | 37101 | 110550982 |
| Dyspnoea | 86.71 | 52.51 | 81 | 1135 | 1106791 | 109481292 |
| Hypoxia | 85.47 | 52.51 | 37 | 1179 | 129478 | 110458605 |
| Oxygen saturation decreased | 66.50 | 52.51 | 33 | 1183 | 156949 | 110431134 |
| Flushing | 62.80 | 52.51 | 28 | 1188 | 104708 | 110483375 |
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| Source | Code | Description |
|---|---|---|
| ATC | J06BD07 | ANTIINFECTIVES FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS IMMUNOGLOBULINS Antiviral monoclonal antibodies |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:149553 | anticoronaviral agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| COVID-19 | indication | 840539006 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Spike glycoprotein | Glycoprotein | BINDING AGENT | Kd | 10.33 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11939 | KEGG_DRUG |
| 2Z3DQD2JHM | UNII |
| C5422689 | UMLSCUI |
| CHEBI:758155 | CHEBI |
| CHEMBL4650249 | ChEMBL_ID |
| DB15940 | DRUGBANK_ID |
| 11863 | INN_ID |
| C000711488 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11328 | IUPHAR_LIGAND_ID |
| 1137367000 | SNOMEDCT_US |
| 1162695009 | SNOMEDCT_US |
| 4039879 | VANDF |
| 341255 | MMSL |
| 39042 | MMSL |
| d09685 | MMSL |
| 018564 | NDDF |
| 2465249 | RXNORM |
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