|
gptkbp:instanceOf
|
gptkb:drug
gptkb:monoclonal_antibody
|
|
gptkbp:administeredBy
|
gptkb:physician
|
|
gptkbp:approvalYear
|
2021-06-07
|
|
gptkbp:approvedBy
|
gptkb:FDA
|
|
gptkbp:ATCCode
|
N06DX01
|
|
gptkbp:brand
|
gptkb:Aduhelm
|
|
gptkbp:CASNumber
|
1303115-46-7
|
|
gptkbp:chemicalFormula
|
C6472H10054N1732O2013S46
|
|
gptkbp:clinicalTrialPhase
|
gptkb:EMERGE
gptkb:ENGAGE
Phase 3
|
|
gptkbp:compatibleWith
|
gptkb:Canada
gptkb:European_Union
gptkb:Japan
|
|
gptkbp:controversy
|
FDA approval process criticized
efficacy questioned
|
|
gptkbp:cost
|
$56,000 per year (initially)
|
|
gptkbp:countryOfOperation
|
gptkb:United_States
|
|
gptkbp:developedBy
|
gptkb:Biogen
gptkb:Eisai
|
|
gptkbp:firstBook
|
yes
|
|
gptkbp:genericName
|
gptkb:aducanumab
|
|
gptkbp:halfLife
|
24.8 days
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Aduhelm
|
|
gptkbp:indication
|
gptkb:Alzheimer's_disease
|
|
gptkbp:legalStatus
|
prescription only
|
|
gptkbp:macromoleculeType
|
gptkb:amyloid_beta_plaques
|
|
gptkbp:marketedAs
|
gptkb:Biogen
gptkb:Eisai
|
|
gptkbp:mechanismOfAction
|
reduces amyloid beta plaques
|
|
gptkbp:patent
|
gptkb:Biogen
gptkb:Eisai
|
|
gptkbp:pregnancyCategory
|
not assigned
|
|
gptkbp:prescriptionRequired
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf
|
|
gptkbp:prescriptionStatus
|
prescription only
|
|
gptkbp:riskEvaluation
|
REMS program not required
|
|
gptkbp:routeOfAdministration
|
intravenous
|
|
gptkbp:sideEffect
|
gptkb:amyloid-related_imaging_abnormalities_(ARIA)
confusion
nausea
diarrhea
dizziness
falls
headache
vision changes
|
|
gptkbp:storage
|
2°C to 8°C
|
|
gptkbp:target
|
gptkb:amyloid_beta_protein
|
|
gptkbp:type
|
human monoclonal antibody
|
|
gptkbp:UNII
|
J9PK1J6UUL
|
|
gptkbp:withdrawn
|
2024 (US)
|
|
gptkbp:bfsParent
|
gptkb:Biogen
|
|
gptkbp:bfsLayer
|
5
|