Leqembi lecanemab

Drug Class

Amyloid-beta-directed monoclonal antibody

Mechanism

Lecanemab is a humanized IgG1 monoclonal antibody that selectively binds to soluble amyloid-beta (Abeta) protofibrils, promoting their clearance and preventing deposition into amyloid plaques.

Approved Indication

Treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage with confirmed amyloid pathology.

What This Means For Patients

Leqembi is a disease-modifying monoclonal antibody therapy for early-stage Alzheimer's disease. Administered intravenously every two weeks, it targets and clears amyloid-beta protofibrils to slow clinical decline. Following approval by the FDA, EMA, and China's NMPA, it is available for clinical use under special access regulations in Boao Lecheng.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2025) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• Clarity AD — van Dyck et al., N Engl J Med 2023 (NCT03887416) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s001lbl.pdf
• https://www.eisai.com/news/2024/news202401.html
• https://www.ema.europa.eu/