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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (human origin); immunomodulator | 5474 | 1326232-46-5 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Anifrolumab-fnia is a human IgG1kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets. Type I IFNs play a role in the pathogenesis of SLE. Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.
|
| Dose | Unit | Route |
|---|---|---|
| 10.70 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 30, 2021 | FDA | ASTRAZENECA AB | |
| Sept. 27, 2021 | PMDA | ASTRAZENECA K.K. | |
| Feb. 14, 2022 | EMA | ASTRA ZENECA AB |
| 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 |
|---|---|---|---|---|---|---|
| Lupus nephritis | 138.14 | 26.62 | 29 | 1699 | 4803 | 90621916 |
| Herpes zoster | 76.93 | 26.62 | 37 | 1691 | 94607 | 90532112 |
| Off label use | 53.16 | 26.62 | 83 | 1645 | 1102169 | 89524550 |
| Proteinuria | 52.91 | 26.62 | 19 | 1709 | 23272 | 90603447 |
| COVID-19 | 47.28 | 26.62 | 33 | 1695 | 168810 | 90457909 |
| Dermatitis bullous | 29.51 | 26.62 | 10 | 1718 | 10306 | 90616413 |
None
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 74.22 | 34.29 | 85 | 1108 | 1500100 | 109088006 |
| Lupus nephritis | 70.67 | 34.29 | 15 | 1178 | 4630 | 110583476 |
| Herpes zoster | 68.87 | 34.29 | 30 | 1163 | 108349 | 110479757 |
| Treatment failure | 35.64 | 34.29 | 27 | 1166 | 277207 | 110310899 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AG11 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Monoclonal antibodies |
| FDA EPC | N0000193967 | Type I Interferon Receptor Antagonist |
| FDA MoA | N0000193968 | Type I Interferon Receptor Antagonists |
| CHEBI has role | CHEBI:35842 | antirheumatic drug |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Moderate to severe systemic lupus erythematosus (SLE) | indication | 55464009 | DOID:9074 |
None
None
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interferon alpha/beta receptor 1 | Membrane receptor | ANTIBODY BINDING | Kd | 9.54 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 38RL9AE51Q | UNII |
| C4519739 | UMLSCUI |
| CHEBI:755000 | CHEBI |
| CHEMBL2364653 | ChEMBL_ID |
| DB11976 | DRUGBANK_ID |
| D11082 | KEGG_DRUG |
| 9800 | INN_ID |
| C582345 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8258 | IUPHAR_LIGAND_ID |
| 842825221000119100 | SNOMEDCT_US |
| 4040742 | VANDF |
| 4040743 | VANDF |
| 349045 | MMSL |
| 39758 | MMSL |
| d09779 | MMSL |
| 018820 | NDDF |
| 2565265 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SAPHNELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-3040 | INJECTION, SOLUTION | 300 mg | INTRAVENOUS | BLA | 27 sections |
| SAPHNELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-3080 | INJECTION, SOLUTION | 120 mg | SUBCUTANEOUS | BLA | 27 sections |