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| Stem definition | Drug id | CAS RN |
|---|---|---|
| human origin | 5464 | 1384260-65-4 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Aducanumab-avwa is a human, 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’s disease. ADUHELM reduces amyloid beta plaques, as evaluated in Studies 1, 2, and 3.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 7, 2021 | FDA | BIOGEN 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 | 548.49 | 115.64 | 58 | 132 | 886 | 90627371 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 332.94 | 115.64 | 36 | 154 | 637 | 90627620 |
| 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 | 454.09 | 134.41 | 51 | 130 | 651 | 42620503 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 364.35 | 134.41 | 42 | 139 | 663 | 42620491 |
| 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 | 913.15 | 110.55 | 100 | 231 | 1475 | 110587493 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 610.38 | 110.55 | 69 | 262 | 1297 | 110587671 |
| Superficial siderosis of central nervous system | 171.57 | 110.55 | 18 | 313 | 147 | 110588821 |
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| Source | Code | Description |
|---|---|---|
| ATC | N06DX03 | 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 | EC50 | 10 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 105J35OE21 | UNII |
| D10541 | KEGG_DRUG |
| C4043101 | UMLSCUI |
| CHEBI:755082 | CHEBI |
| CHEMBL3039540 | ChEMBL_ID |
| DB12274 | DRUGBANK_ID |
| 9838 | INN_ID |
| C000600266 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8325 | IUPHAR_LIGAND_ID |
| 1162583000 | SNOMEDCT_US |
| 1162609005 | SNOMEDCT_US |
| 4040592 | VANDF |
| 4040593 | VANDF |
| 347165 | MMSL |
| 39568 | MMSL |
| d09759 | MMSL |
| 018764 | NDDF |
| 2557217 | RXNORM |
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