Leqembi

E25439

Leqembi is an Alzheimer’s disease drug (lecanemab) that targets amyloid-beta plaques to slow cognitive decline in early-stage patients.

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All labels observed (5)

Label Occurrences
lecanemab 8
Leqembi canonical 7
Lecanemab 2

Statements (48)

Predicate Object
instanceOf Alzheimer’s disease drug
drug
monoclonal antibody
administeredTo adult patients
approvedBy Food and Drug Administration
surface form: 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 of America
surface form: 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 Leqembi self-linksurface differs
surface form: lecanemab
hasIndication Alzheimer's disease
surface form: Alzheimer’s disease

mild cognitive impairment due to Alzheimer’s disease
mild dementia stage of Alzheimer’s disease
hasINN Leqembi self-linksurface differs
surface form: 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

Referenced by (19)

Full triples — surface form annotated when it differs from this entity's canonical label.

Biogen hasProduct Leqembi
Leqembi hasGenericName Leqembi self-linksurface differs
this entity surface form: lecanemab
Leqembi hasINN Leqembi self-linksurface differs
this entity surface form: lecanemab
Eisai hasProduct Leqembi
this entity surface form: Lecanemab
Eisai hasProduct Leqembi
Eisai developed Leqembi
this entity surface form: Lecanemab
Eisai developed Leqembi
Eisai developedForIndication Leqembi
this entity surface form: Leqembi – Alzheimer’s disease
CLARITY AD evaluatesDrug Leqembi
this entity surface form: lecanemab
CLARITY AD evaluatesDrug Leqembi
CLARITY AD drugBrandName Leqembi
CLARITY AD drugGenericName Leqembi
this entity surface form: lecanemab
Study 301 evaluatesDrug Leqembi
Study 301 evaluatesDrug Leqembi
this entity surface form: lecanemab
Study 301 sponsorDrugBrand Leqembi
Study 301 sponsorDrugGeneric Leqembi
this entity surface form: lecanemab
ARIA-H (amyloid-related imaging abnormalities with microhemorrhages and hemosiderin deposits) associatedWith Leqembi
subject surface form: ARIA-H
this entity surface form: lecanemab
ARIA-H (amyloid-related imaging abnormalities with microhemorrhages and hemosiderin deposits) associatedWith Leqembi
subject surface form: ARIA-H
this entity surface form: donanemab
Eisai and Biogen developed Leqembi
this entity surface form: lecanemab