Leqembi
E25439
Leqembi is an Alzheimer’s disease drug (lecanemab) that targets amyloid-beta plaques to slow cognitive decline in early-stage patients.
Aliases (3)
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
Alzheimer’s disease drug
→
drug → monoclonal antibody → |
| administeredTo |
adult patients
→
|
| approvedBy |
U.S. Food and Drug Administration
→
|
| belongsToTherapeuticArea |
neurodegenerative diseases
→
neurology → |
| coDevelopedBy |
Eisai and Biogen
→
|
| developedBy |
Biogen
→
Eisai → |
| hasATCClass |
N06DX
→
|
| hasBiomarkerTarget |
amyloid-beta protofibrils
→
|
| hasBrandOwner |
Eisai
→
|
| hasCommonAdverseEffect |
ARIA-E (amyloid-related imaging abnormalities with edema)
→
ARIA-H (amyloid-related imaging abnormalities with microhemorrhages and hemosiderin deposits) → headache → infusion-related reactions → |
| hasContraindicationNote |
caution in patients on anticoagulant therapy
→
|
| hasCoPromotionPartner |
Biogen
→
|
| hasCountryOfApproval |
United States
→
|
| hasDosageForm |
solution for intravenous infusion
→
|
| hasDosingFrequency |
every two weeks
→
|
| hasDrugClass |
anti-amyloid beta monoclonal antibody
→
|
| hasEffect |
slows cognitive decline compared with placebo in early Alzheimer’s disease
→
|
| hasFDAIndicationText |
treatment of Alzheimer’s disease
→
|
| hasGenericName |
lecanemab
→
|
| hasIndication |
Alzheimer’s disease
→
mild cognitive impairment due to Alzheimer’s disease → mild dementia stage of Alzheimer’s disease → |
| hasINN |
lecanemab
→
|
| hasKeyClinicalTrial |
CLARITY AD
→
Study 201 → Study 301 → |
| hasMolecularType |
humanized IgG1 monoclonal antibody
→
|
| hasRegulatoryPathway |
FDA traditional approval
→
|
| hasRegulatoryStatus |
FDA approved
→
|
| hasRouteOfAdministration |
intravenous infusion
→
|
| hasWarning |
risk of ARIA
→
|
| indicatedFor |
early-stage Alzheimer’s disease
→
|
| isAdministeredIn |
hospital or infusion center settings
→
|
| isFirstInClass |
first anti-amyloid Alzheimer’s drug with full FDA approval (as of 2023)
→
|
| isUsedWith |
MRI monitoring for ARIA
→
|
| mechanismOfAction |
binds aggregated soluble and insoluble amyloid-beta
→
reduces amyloid-beta plaques in the brain → |
| previouslyHadRegulatoryPathway |
FDA accelerated approval
→
|
| requires |
confirmation of amyloid-beta pathology
→
|
| targets |
amyloid-beta
→
amyloid-beta plaques → |