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BIIB·Biogen

LEQEMBI

Genericlecanemab
mAbhumanized anti-amyloid beta protofibril mAb

LEQEMBI (lecanemab) is a humanized monoclonal antibody co-developed by Biogen and Eisai that targets and clears amyloid-beta protofibrils — a soluble, toxic form of amyloid thought to drive early Alzheimer's neurodegeneration. By reducing amyloid burden in the brain, it slows the rate of clinical decline in patients with mild cognitive impairment or mild Alzheimer's dementia. LEQEMBI received full FDA approval in 2023 as the first anti-amyloid therapy to demonstrate statistically significant slowing of functional decline in a Phase 3 trial; it is given by IV infusion every two weeks, with an at-home autoinjector in development for the maintenance phase.

Upcoming catalysts

1 of 1

Programs

1 program
completedNeurology

Alzheimer's Disease

Alzheimer's disease is the leading cause of dementia, affecting over 6 million Americans with no prior disease-modifying treatment approved until 2023. LEQEMBI is indicated for early symptomatic Alzheimer's with confirmed amyloid pathology; this program focuses on the commercial rollout phase, including the launch of the IQLIK at-home autoinjector to replace the burdensome every-two-week IV infusion clinic visits for patients who complete the 18-month induction phase.

Trial
NCT01767311n=1,795completed
Clarity AD: Open-Label Extension of Lecanemab
Primary completion: Dec 15, 2024
CMC
JUL 252026·3 monthsEXACT
LEQEMBI Subcutaneous Maintenance Launch

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