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| Stem definition | Drug id | CAS RN |
|---|---|---|
| primate origin | 5455 | 2415933-42-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Casirivimab with imdevimab 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 |
|---|---|---|---|---|---|---|
| Wrong product administered | 129.09 | 49.65 | 25 | 611 | 7640 | 90620171 |
| Infusion related reaction | 105.50 | 49.65 | 53 | 583 | 416727 | 90211084 |
| COVID-19 pneumonia | 81.54 | 49.65 | 20 | 616 | 18157 | 90609654 |
| Flushing | 64.76 | 49.65 | 24 | 612 | 88467 | 90539344 |
| 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 | 126.57 | 46.28 | 43 | 574 | 60763 | 42559955 |
| Wrong product administered | 99.43 | 46.28 | 22 | 595 | 6204 | 42614514 |
| COVID-19 pneumonia | 72.27 | 46.28 | 22 | 595 | 21591 | 42599127 |
| 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 |
|---|---|---|---|---|---|---|
| Wrong product administered | 229.49 | 52.99 | 47 | 1302 | 10913 | 110577037 |
| Infusion related reaction | 205.58 | 52.99 | 97 | 1252 | 381065 | 110206885 |
| COVID-19 pneumonia | 153.91 | 52.99 | 43 | 1306 | 37100 | 110550850 |
| Dyspnoea | 86.84 | 52.99 | 85 | 1264 | 1106787 | 109481163 |
| Hypoxia | 81.73 | 52.99 | 37 | 1312 | 129478 | 110458472 |
| Oxygen saturation decreased | 69.02 | 52.99 | 35 | 1314 | 156947 | 110431003 |
| Flushing | 63.11 | 52.99 | 29 | 1320 | 104707 | 110483243 |
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| Source | Code | Description |
|---|---|---|
| ATC | J06BD07 | ANTIINFECTIVES FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS IMMUNOGLOBULINS Antiviral monoclonal antibodies |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| 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 | 10.34 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11938 | KEGG_DRUG |
| J0FI6WE1QN | UNII |
| C5422688 | UMLSCUI |
| CHEBI:758154 | CHEBI |
| CHEMBL4650248 | ChEMBL_ID |
| DB15941 | DRUGBANK_ID |
| 11861 | INN_ID |
| C000711487 | MESH_SUPPLEMENTAL_RECORD_UI |
| C000711751 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11327 | IUPHAR_LIGAND_ID |
| 1137366009 | SNOMEDCT_US |
| 1162700002 | SNOMEDCT_US |
| 4039878 | VANDF |
| 2415933-42-3 | SECONDARY_CAS_RN |
| 341252 | MMSL |
| 343591 | MMSL |
| 39041 | MMSL |
| d09684 | MMSL |
| 018563 | NDDF |
| 2465242 | RXNORM |
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