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| Stem definition | Drug id | CAS RN |
|---|---|---|
| chimeric/humanized | 5735 | 1584645-37-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 26, 2023 | FDA | UCB INC |
| 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 |
|---|---|---|---|---|---|---|
| Meningitis aseptic | 45.97 | 42.39 | 9 | 264 | 6764 | 90621410 |
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| 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 | 54.95 | 46.69 | 9 | 446 | 1805 | 110587039 |
| Meningitis aseptic | 50.79 | 46.69 | 11 | 444 | 9859 | 110578985 |
| Headache | 46.74 | 46.69 | 34 | 421 | 882343 | 109706501 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AL02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Neonatal fragment crystallizable receptor (FcRn) inhibitors |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| FDA EPC | N0000194004 | Neonatal Fc Receptor Blocker |
| FDA MoA | N0000194005 | Neonatal Fc Receptor Blockers |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Generalized 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 | ANTIBODY BINDING | Kd | 10.47 | SCIENTIFIC LITERATURE | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757264 | CHEBI |
| CHEMBL4297820 | ChEMBL_ID |
| C000627812 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9801 | IUPHAR_LIGAND_ID |
| DB14919 | DRUGBANK_ID |
| 42755511000001109 | SNOMEDCT_US |
| 4042357 | VANDF |
| 4042358 | VANDF |
| C4726717 | UMLSCUI |
| 10213 | INN_ID |
| 368620 | MMSL |
| 41734 | MMSL |
| d10075 | MMSL |
| 019481 | NDDF |
| D12182 | KEGG_DRUG |
| P7186074QC | UNII |
| 2642273 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| RYSTIGGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-980 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 29 sections |
| RYSTIGGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-981 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 29 sections |
| RYSTIGGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-982 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 29 sections |
| RYSTIGGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-983 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 29 sections |