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| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 5397 | 1299440-37-1 |
| Molecule | Description |
|---|---|
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Synonyms:
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Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD is unknown but is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis (ADCC).
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 11, 2020 | FDA | VIELA BIO | |
| March 23, 2021 | PMDA | Mitsubishi Tanabe Pharma Corporation | |
| April 25, 2022 | EMA | Horizon Therapeutics Ireland DAC |
| 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 |
|---|---|---|---|---|---|---|
| Neuromyelitis optica spectrum disorder | 50.28 | 44.12 | 8 | 330 | 1482 | 90626627 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AG10 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Monoclonal antibodies |
| FDA MoA | N0000191422 | CD19-directed Antibody Interactions |
| FDA EPC | N0000194013 | CD19-directed Cytolytic Antibody |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Neuromyelitis optica | indication | 25044007 | DOID:8869 |
| Tuberculosis | contraindication | 56717001 | |
| Viral hepatitis type B | contraindication | 66071002 | DOID:2043 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| B-lymphocyte antigen CD19 | Surface antigen | ANTIBODY BINDING | Kd | 9.80 | IUPHAR | DRUG LABEL | |||
| Low affinity immunoglobulin gamma Fc region receptor III-A | Membrane receptor | ANTIBODY BINDING | Kd | 7.11 | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| D11757 | KEGG_DRUG |
| 74T7185BMM | UNII |
| 4039495 | VANDF |
| 4039496 | VANDF |
| C4519594 | UMLSCUI |
| CHEBI:754166 | CHEBI |
| CHEMBL2109334 | ChEMBL_ID |
| DB12530 | DRUGBANK_ID |
| 9985 | INN_ID |
| C000609745 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7992 | IUPHAR_LIGAND_ID |
| 879883007 | SNOMEDCT_US |
| 879892005 | SNOMEDCT_US |
| 335069 | MMSL |
| 38531 | MMSL |
| d09575 | MMSL |
| 018404 | NDDF |
| 2373950 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| UPLIZNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-150 | INJECTION | 10 mg | INTRAVENOUS | BLA | 30 sections |