| 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. 12, 2021 | EMA | ROCHE REGISTRATION GMBH | |
| Nov. 21, 2020 | FDA | Regeneron Pharmaceuticals, Inc. | |
| July 19, 2021 | PMDA | CHUGAI PHARMACEUTICAL Co., Ltd |
| 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 | 124.88 | 45.87 | 25 | 633 | 6116 | 63482248 |
| Infusion related reaction | 112.46 | 45.87 | 53 | 605 | 245468 | 63242896 |
| COVID-19 pneumonia | 78.68 | 45.87 | 20 | 638 | 14189 | 63474175 |
| Flushing | 62.97 | 45.87 | 25 | 633 | 75062 | 63413302 |
| 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 | 125.77 | 47.77 | 43 | 549 | 53014 | 34903325 |
| Wrong product administered | 99.40 | 47.77 | 22 | 570 | 5312 | 34951027 |
| COVID-19 pneumonia | 69.78 | 47.77 | 21 | 571 | 16946 | 34939393 |
| Hypoxia | 48.84 | 47.77 | 22 | 570 | 55073 | 34901266 |
| 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 | 223.69 | 51.87 | 47 | 1292 | 8965 | 79734084 |
| Infusion related reaction | 222.78 | 51.87 | 97 | 1242 | 230140 | 79512909 |
| COVID-19 pneumonia | 146.56 | 51.87 | 42 | 1297 | 28807 | 79714242 |
| Dyspnoea | 82.27 | 51.87 | 85 | 1254 | 856940 | 78886109 |
| Hypoxia | 81.55 | 51.87 | 38 | 1301 | 103205 | 79639844 |
| Oxygen saturation decreased | 64.95 | 51.87 | 35 | 1304 | 129012 | 79614037 |
| Flushing | 62.02 | 51.87 | 30 | 1309 | 88238 | 79654811 |
None
| 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 |
| 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 |
| CHEMBL4650248 | ChEMBL_ID |
| DB15941 | DRUGBANK_ID |
| 11861 | INN_ID |
| C000711751 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11327 | IUPHAR_LIGAND_ID |
| 018563 | NDDF |
| 1137366009 | SNOMEDCT_US |
| 1162700002 | SNOMEDCT_US |
| 4039878 | VANDF |
| 2415933-42-3 | SECONDARY_CAS_RN |
| 2465242 | RXNORM |
| 341252 | MMSL |
| 343591 | MMSL |
| 39041 | MMSL |
| d09684 | MMSL |
| C000711487 | MESH_SUPPLEMENTAL_RECORD_UI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Casirivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-024 | INJECTION, SOLUTION, CONCENTRATE | 1332 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |
| Casirivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-024 | INJECTION, SOLUTION, CONCENTRATE | 1332 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |
| Casirivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-026 | INJECTION, SOLUTION, CONCENTRATE | 300 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |
| Casirivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-026 | INJECTION, SOLUTION, CONCENTRATE | 300 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |
| REGEN-COV | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61755-039 | INJECTION, SOLUTION, CONCENTRATE | 600 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |
| REGEN-COV | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61755-039 | INJECTION, SOLUTION, CONCENTRATE | 600 mg | INTRAVENOUS | UNAPPROVED DRUG OTHER | 32 sections |