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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies | 5814 | None |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Crovalimab is a recombinant humanized monoclonal IgG1 antibody that binds to complement protein C5. By binding to C5, crovalimab inhibits its cleavage into C5a and C5b, thereby preventing formation of the membrane attack complex (MAC).
|
| Dose | Unit | Route |
|---|---|---|
| 24.30 | mg | P |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 26, 2024 | PMDA | Chugai Pharmaceutical Co., Ltd. | |
| June 20, 2024 | FDA | Genentech, Inc. | |
| Aug. 22, 2024 | EMA | Roche Registration GmbH |
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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 |
|---|---|---|---|---|---|---|
| Type III immune complex mediated reaction | 92.60 | 67.07 | 11 | 60 | 571 | 42620693 |
| 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 |
|---|---|---|---|---|---|---|
| Type III immune complex mediated reaction | 142.60 | 64.04 | 17 | 141 | 1036 | 110588105 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AJ07 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Complement inhibitors |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| MeSH PA | D051056 | Complement Inactivating Agents |
| FDA EPC | N0000194109 | Complement C5 Inhibitor |
| FDA MoA | N0000194110 | Complement C5 Inhibitors |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Paroxysmal nocturnal hemoglobinuria | indication | 1963002 | DOID:0060284 |
| Unresolved serious infection caused by Neisseria meningitidis | contraindication | 23511006 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Complement C5 | Secreted | COMPLEMENT INHIBITOR | Kd | 9.76 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEMBL4594316 | ChEMBL_ID |
| DB16128 | DRUGBANK_ID |
| 4043279 | VANDF |
| 4043280 | VANDF |
| C5925709 | UMLSCUI |
| CHEBI:757815 | CHEBI |
| 1917321-26-6 | SECONDARY_CAS_RN |
| 386417 | MMSL |
| 42925 | MMSL |
| d10196 | MMSL |
| 019794 | NDDF |
| 12790 | IUPHAR_LIGAND_ID |
| 10882 | INN_ID |
| 2686619 | RXNORM |
| 43789811000001106 | SNOMEDCT_US |
| C000731754 | MESH_SUPPLEMENTAL_RECORD_UI |
| D11696 | KEGG_DRUG |
| H9KH1GP3UU | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Piasky | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-115 | INJECTION, SOLUTION | 340 mg | SUBCUTANEOUS | BLA | 29 sections |