| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 5409 | 1535963-91-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. It is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients. The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.
|
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 24, 2021 | EMA | Roche Registration GmbH | |
| Aug. 14, 2020 | FDA | GENENTECH | |
| June 29, 2020 | PMDA | Chugai Pharmaceutical Co., Ltd. |
| 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 |
|---|---|---|---|---|---|---|
| Urinary tract infection | 47.75 | 39.40 | 25 | 333 | 264659 | 63224005 |
| Myelitis | 40.57 | 39.40 | 7 | 351 | 1396 | 63487268 |
None
None
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AC19 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Neuromyelitis optica | indication | 25044007 | DOID:8869 |
| Tuberculosis | contraindication | 56717001 | |
| Viral hepatitis type B | contraindication | 66071002 | DOID:2043 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interleukin-6 receptor | Membrane receptor | ANTAGONIST | Kd | 8.82 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11079 | KEGG_DRUG |
| YB18NF020M | UNII |
| C4726732 | UMLSCUI |
| CHEMBL3833307 | ChEMBL_ID |
| DB15762 | DRUGBANK_ID |
| 9093 | IUPHAR_LIGAND_ID |
| 018474 | NDDF |
| 897234001 | SNOMEDCT_US |
| 897291006 | SNOMEDCT_US |
| 4039644 | VANDF |
| 4039645 | VANDF |
| 2391541 | RXNORM |
| 337831 | MMSL |
| 38756 | MMSL |
| d09618 | MMSL |
| C000655944 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10065 | INN_ID |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Enspryng | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-007 | INJECTION, SOLUTION | 120 mg | SUBCUTANEOUS | BLA | 28 sections |
| Enspryng | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-007 | INJECTION, SOLUTION | 120 mg | SUBCUTANEOUS | BLA | 28 sections |
| Enspryng | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-007 | INJECTION, SOLUTION | 120 mg | SUBCUTANEOUS | BLA | 28 sections |