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Leqembi

Approved

Lecanemab

Biogen Inc. (BIIB)
Fast TrackBreakthrough TherapyLearn about designations

Approved

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Drug Information

Target Indication

Alzheimer Disease

Mechanism of Action

Anti-Amyloid Antibody

Clinical Trial

NCT03887455

Last updated: 12/3/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA4/15/2025

Leqembi

Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).

View on EMA
Drug Science
Mechanism of action & safety profile
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