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| Stem definition | Drug id | CAS RN |
|---|---|---|
| immunomodulators, both stimulant/suppressive and stimulant | 5499 | 1821402-21-4 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 12, 2021 | FDA | ARGENX BV | |
| March 21, 2018 | EMA | Argenx | |
| Jan. 20, 2022 | PMDA | Argenx Japan K.K. |
| 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 |
|---|---|---|---|---|---|---|
| Myasthenia gravis crisis | 143.29 | 42.91 | 20 | 475 | 1044 | 90626908 |
| Symptom recurrence | 117.02 | 42.91 | 20 | 475 | 3939 | 90624013 |
| 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 |
|---|---|---|---|---|---|---|
| Myasthenia gravis crisis | 76.07 | 53.23 | 11 | 197 | 835 | 42620292 |
| 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 |
|---|---|---|---|---|---|---|
| Myasthenia gravis crisis | 134.45 | 45.10 | 20 | 530 | 1794 | 110586955 |
| Symptom recurrence | 88.47 | 45.10 | 16 | 534 | 4756 | 110583993 |
| Off label use | 46.54 | 45.10 | 46 | 504 | 1500139 | 109088610 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AL01 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Neonatal fragment crystallizable receptor (FcRn) inhibitors |
| FDA EPC | N0000194004 | Neonatal Fc Receptor Blocker |
| FDA MoA | N0000194005 | Neonatal Fc Receptor Blockers |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Immune thrombocytopenia | indication | 2897005 | DOID:1587 |
| Myasthenia gravis | indication | 91637004 | DOID:437 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| IgG receptor FcRn large subunit p51 | Membrane receptor | INHIBITOR | Kd | 8.07 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757026 | CHEBI |
| CHEMBL4297551 | ChEMBL_ID |
| C000718373 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9777 | IUPHAR_LIGAND_ID |
| DB15270 | DRUGBANK_ID |
| 41621711000001108 | SNOMEDCT_US |
| 4041066 | VANDF |
| 4041067 | VANDF |
| C5139924 | UMLSCUI |
| D11876 | KEGG_DRUG |
| 10455 | INN_ID |
| 354396 | MMSL |
| 40184 | MMSL |
| 40196 | MMSL |
| d09842 | MMSL |
| 018912 | NDDF |
| 961YV2O515 | UNII |
| 2587717 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VYVGART Hytrulo | HUMAN PRESCRIPTION DRUG LABEL | 2 | 73475-1221 | INJECTION, SOLUTION | 200 mg | SUBCUTANEOUS | BLA | 32 sections |
| VYVGART Hytrulo | HUMAN PRESCRIPTION DRUG LABEL | 2 | 73475-1221 | INJECTION, SOLUTION | 200 mg | SUBCUTANEOUS | BLA | 32 sections |
| VYVGART | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73475-3041 | INJECTION | 20 mg | INTRAVENOUS | BLA | 30 sections |
| VYVGART | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73475-3041 | INJECTION | 20 mg | INTRAVENOUS | BLA | 30 sections |
| VYVGART Hytrulo | HUMAN PRESCRIPTION DRUG LABEL | 2 | 73475-3102 | INJECTION, SOLUTION | 180 mg | SUBCUTANEOUS | BLA | 32 sections |
| VYVGART Hytrulo | HUMAN PRESCRIPTION DRUG LABEL | 2 | 73475-3102 | INJECTION, SOLUTION | 180 mg | SUBCUTANEOUS | BLA | 32 sections |