| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (human origin); immunomodulator | 5474 | 1326232-46-5 |
| Molecule | Description |
|---|---|
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Synonyms:
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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.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 14, 2022 | EMA | ASTRA ZENECA AB | |
| July 30, 2021 | FDA | ASTRAZENECA AB | |
| Sept. 27, 2021 | PMDA | ASTRAZENECA K.K. |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AA51 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
| FDA EPC | N0000193967 | Type I Interferon Receptor Antagonist |
| FDA MoA | N0000193968 | Type I Interferon Receptor Antagonists |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Moderate to severe systemic lupus erythematosus (SLE) | indication | 55464009 | DOID:9074 |
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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 |
| CHEMBL2364653 | ChEMBL_ID |
| DB11976 | DRUGBANK_ID |
| D11082 | KEGG_DRUG |
| 9800 | INN_ID |
| 8258 | IUPHAR_LIGAND_ID |
| 018820 | NDDF |
| 4040742 | VANDF |
| 4040743 | VANDF |
| 2565265 | RXNORM |
| 349045 | MMSL |
| 39758 | MMSL |
| d09779 | MMSL |
| C582345 | MESH_SUPPLEMENTAL_RECORD_UI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SAPHNELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-3040 | INJECTION, SOLUTION | 300 mg | INTRAVENOUS | BLA | 26 sections |
| SAPHNELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-3040 | INJECTION, SOLUTION | 300 mg | INTRAVENOUS | BLA | 26 sections |