aducanumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
human origin	5464	1384260-65-4

Description:

Molecule	Description
Molfile Synonyms: aducanumab aducanumab-avwa aduhelm BIIB037	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. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

aducanumab
aducanumab-avwa
aduhelm
BIIB037

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.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 7, 2021	FDA	BIOGEN INC

FDA Adverse Event Reporting System (Female)

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	396.23	98.41	37	87	147	63488751
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	207	98.41	19	105	53	63488845

FDA Adverse Event Reporting System (Male)

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	348.61	103.87	36	93	225	34956577
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	230.13	103.87	24	105	157	34956645

FDA Adverse Event Reporting System (Geriatric)

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	657.91	95.60	65	148	362	79743813
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	364.22	95.60	36	177	183	79743992

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Alzheimer's disease	indication	26929004	DOID:10652

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Amyloid beta A4 protein	Unclassified	P05067	A4_HUMAN	ANTIBODY BINDING	EC50	10		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
105J35OE21	UNII
D10541	KEGG_DRUG
C4043101	UMLSCUI
CHEMBL3039540	ChEMBL_ID
DB12274	DRUGBANK_ID
9838	INN_ID
8325	IUPHAR_LIGAND_ID
018764	NDDF
1162583000	SNOMEDCT_US
1162609005	SNOMEDCT_US
4040592	VANDF
4040593	VANDF
2557217	RXNORM
347165	MMSL
39568	MMSL
d09759	MMSL
C000600266	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-101	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-101	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-101	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-102	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-102	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections
Aduhelm	HUMAN PRESCRIPTION DRUG LABEL	1	64406-102	INJECTION, SOLUTION	100 mg	INTRAVENOUS	BLA	27 sections