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| Stem definition | Drug id | CAS RN |
|---|---|---|
| primate origin | 5454 | 2423948-94-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
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FDA issued an Emergency Use Authorization (EUA) for etesevimab and bamlanivimab on February 9, 2021 that permits combined use of the drugs for the treatment of mild to moderate COVID-19. The EUA of bamlanivimab ALONE was revoked by FDA but the use of bamlanivimab in a combined regimen with etesevimab remains unchanged. Etesevimab is a recombinant neutralizing human IgG1kappa mAb to the spike protein of SARS-CoV-2, with amino acid substitutions in the Fc region (L234A, L235A) to reduce effector function. Etesevimab binds the spike protein and blocks spike protein attachment to the human ACE2 receptor with an IC50value of 0.32 nM (0.046 μg/mL). Bamlanivimab and etesevimab bind to different but overlapping epitopes in the receptor binding domain (RBD) of the S-protein. Using both antibodies together is expected to reduce the risk of viral resistance.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 9, 2020 | FDA | Eli Lilly and Company |
| 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 | 430.79 | 56.25 | 183 | 1348 | 416597 | 90210319 |
| Flushing | 287.07 | 56.25 | 91 | 1440 | 88400 | 90538516 |
| Dyspnoea | 208.11 | 56.25 | 146 | 1385 | 880809 | 89746107 |
| Chest discomfort | 206.98 | 56.25 | 80 | 1451 | 138285 | 90488631 |
| COVID-19 pneumonia | 103.47 | 56.25 | 29 | 1502 | 18148 | 90608768 |
| Oxygen saturation decreased | 64.84 | 56.25 | 33 | 1498 | 107450 | 90519466 |
| Back pain | 60.99 | 56.25 | 47 | 1484 | 317128 | 90309788 |
| 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 | 265.90 | 50.26 | 79 | 673 | 60727 | 42559856 |
| COVID-19 pneumonia | 186.02 | 50.26 | 48 | 704 | 21565 | 42599018 |
| Flushing | 86.04 | 50.26 | 30 | 722 | 36998 | 42583585 |
| 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 | 657.93 | 62.18 | 258 | 2083 | 380904 | 110206054 |
| Flushing | 380.43 | 62.18 | 124 | 2217 | 104612 | 110482346 |
| COVID-19 pneumonia | 268.82 | 62.18 | 75 | 2266 | 37068 | 110549890 |
| Chest discomfort | 232.58 | 62.18 | 99 | 2242 | 173749 | 110413209 |
| Dyspnoea | 226.47 | 62.18 | 185 | 2156 | 1106687 | 109480271 |
| Oxygen saturation decreased | 106.09 | 62.18 | 56 | 2285 | 156926 | 110430032 |
| Back pain | 91.82 | 62.18 | 70 | 2271 | 370926 | 110216032 |
| Acute respiratory failure | 68.82 | 62.18 | 33 | 2308 | 75227 | 110511731 |
| Hyperhidrosis | 66.21 | 62.18 | 44 | 2297 | 187254 | 110399704 |
| Chest pain | 63.65 | 62.18 | 57 | 2284 | 376318 | 110210640 |
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| Source | Code | Description |
|---|---|---|
| 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 | Kd | 8.19 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11944 | KEGG_DRUG |
| N7Q9NLF11I | UNII |
| C5421804 | UMLSCUI |
| CHEBI:758369 | CHEBI |
| CHEMBL4650488 | ChEMBL_ID |
| DB15897 | DRUGBANK_ID |
| 11873 | INN_ID |
| C000711968 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11331 | IUPHAR_LIGAND_ID |
| 127351000202102 | SNOMEDCT_US |
| 4040109 | VANDF |
| 343519 | MMSL |
| 39314 | MMSL |
| d09712 | MMSL |
| 018633 | NDDF |
| 2477854 | RXNORM |
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