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| Stem definition | Drug id | CAS RN |
|---|---|---|
| hamster origin | 5717 | 1260393-98-3 |
| Molecule | Description |
|---|---|
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Synonyms:
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Lecanemab-irmb is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer disease.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 6, 2023 | FDA | EISAI 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 |
|---|---|---|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusion | 2206.27 | 59.78 | 260 | 1767 | 684 | 90625736 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 1728.34 | 59.78 | 202 | 1825 | 471 | 90625949 |
| Infusion related reaction | 278.24 | 59.78 | 149 | 1878 | 416631 | 90209789 |
| Amyloid related imaging abnormalities | 251.63 | 59.78 | 28 | 1999 | 30 | 90626390 |
| Superficial siderosis of central nervous system | 189.86 | 59.78 | 22 | 2005 | 43 | 90626377 |
| Cerebral haemorrhage | 176.85 | 59.78 | 54 | 1973 | 34468 | 90591952 |
| Headache | 140.40 | 59.78 | 130 | 1897 | 862616 | 89763804 |
| Cerebral infarction | 96.37 | 59.78 | 32 | 1995 | 26564 | 90599856 |
| Chills | 89.32 | 59.78 | 48 | 1979 | 131933 | 90494487 |
| Cerebral microhaemorrhage | 64.88 | 59.78 | 10 | 2017 | 241 | 90626179 |
| 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 |
|---|---|---|---|---|---|---|
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 947.49 | 52.05 | 123 | 1174 | 582 | 42619456 |
| Amyloid related imaging abnormality-oedema/effusion | 715.07 | 52.05 | 96 | 1201 | 606 | 42619432 |
| Infusion related reaction | 233.27 | 52.05 | 82 | 1215 | 60724 | 42559314 |
| Amyloid related imaging abnormalities | 149.70 | 52.05 | 17 | 1280 | 14 | 42620024 |
| Chills | 102.58 | 52.05 | 52 | 1245 | 94014 | 42526024 |
| Headache | 90.36 | 52.05 | 67 | 1230 | 239302 | 42380736 |
| Superficial siderosis of central nervous system | 83.41 | 52.05 | 11 | 1286 | 57 | 42619981 |
| Cerebral infarction | 78.39 | 52.05 | 31 | 1266 | 31138 | 42588900 |
| Confusional state | 60.93 | 52.05 | 46 | 1251 | 167551 | 42452487 |
| Cerebral haemorrhage | 55.71 | 52.05 | 26 | 1271 | 38940 | 42581098 |
| 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 |
|---|---|---|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusion | 2457.66 | 51.84 | 309 | 2652 | 1266 | 110585072 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 2310.27 | 51.84 | 288 | 2673 | 1078 | 110585260 |
| Infusion related reaction | 393.37 | 51.84 | 194 | 2767 | 380968 | 110205370 |
| Amyloid related imaging abnormalities | 242.08 | 51.84 | 28 | 2933 | 40 | 110586298 |
| Superficial siderosis of central nervous system | 217.26 | 51.84 | 28 | 2933 | 137 | 110586201 |
| Cerebral haemorrhage | 206.16 | 51.84 | 74 | 2887 | 64894 | 110521444 |
| Headache | 165.11 | 51.84 | 156 | 2805 | 882221 | 109704117 |
| Chills | 149.02 | 51.84 | 81 | 2880 | 190499 | 110395839 |
| Cerebral infarction | 141.89 | 51.84 | 53 | 2908 | 51785 | 110534553 |
| Confusional state | 70.50 | 51.84 | 74 | 2887 | 468606 | 110117732 |
| Cerebral microhaemorrhage | 70.33 | 51.84 | 12 | 2949 | 459 | 110585879 |
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| Source | Code | Description |
|---|---|---|
| ATC | N06DX04 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTI-DEMENTIA DRUGS Other anti-dementia drugs |
| FDA MoA | N0000193950 | Amyloid Beta-directed Antibody Interactions |
| FDA EPC | N0000193951 | Amyloid Beta-directed Antibody |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Alzheimer's disease | indication | 26929004 | DOID:10652 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Amyloid beta A4 protein | Membrane other | ANTIBODY BINDING | IC50 | 6.22 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:755918 | CHEBI |
| CHEMBL3833321 | ChEMBL_ID |
| C000612089 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12202 | IUPHAR_LIGAND_ID |
| DB14580 | DRUGBANK_ID |
| 4041974 | VANDF |
| 4041975 | VANDF |
| C5242453 | UMLSCUI |
| 11194 | INN_ID |
| 364564 | MMSL |
| 41177 | MMSL |
| d09964 | MMSL |
| 019265 | NDDF |
| D11678 | KEGG_DRUG |
| 12PYH0FTU9 | UNII |
| 2626142 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LEQEMBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-212 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | BLA | 29 sections |
| LEQEMBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-215 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | BLA | 29 sections |
| LECANEMAB AUTOINJECTOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-220 | INJECTION, SOLUTION | 200 mg | SUBCUTANEOUS | BLA | 29 sections |
| LECANEMAB AUTOINJECTOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-222 | INJECTION, SOLUTION | 200 mg | SUBCUTANEOUS | BLA | 29 sections |