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European Union

Leqembi (Lecanemab) Marks a Breakthrough in Alzheimer's Treatment with Launch in the EU

Strategic Insights

— 2 min read

The launch of Leqembi (lecanemab) in the EU marks a significant milestone in the treatment of Alzheimer's disease, as it is the first therapy to target an underlying cause of the condition. Leqembi received European Commission approval in April 2025 for the treatment of adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease. The therapy has shown promising results in the Clarity AD clinical trial, reducing clinical decline on the global cognitive and functional scale, Clinical Dementia Rating -- Sum of Boxes (CDR-SB), by 31% at 18 months compared to placebo.

Key Takeaways:

  • Leqembi (lecanemab) is the first therapy to target an underlying cause of Alzheimer's disease, receiving European Commission approval in April 2025.
  • The treatment has shown a 31% reduction in clinical decline on the CDR-SB scale at 18 months compared to placebo in the Clarity AD clinical trial.
  • The most common adverse reactions in the EU indicated population were infusion-related reaction (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%).
  • Symptomatic ARIA-E occurred in 2% of participants, and symptomatic ARIA-H occurred in 0.8% of patients.
  • Leqembi is approved in 48 countries and is under regulatory review in 10 countries.
  • The treatment is administered through a controlled access program in Austria and Germany, enabling the launch in these first two EU countries.
  • The Clarity AD clinical trial was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early Alzheimer's disease (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology).
  • The primary endpoint was the global cognitive and functional scale, CDR-SB, and the treatment group was administered lecanemab 10 mg/kg bi-weekly.

Statistics:

  • 31% reduction in clinical decline on CDR-SB scale at 18 months compared to placebo in the Clarity AD clinical trial.
  • 757 patients in the treatment group received lecanemab, and 764 patients received placebo in the Clarity AD clinical trial.
  • 95% confidence interval for the difference in change from baseline at 18 months was -0.778 to -0.293.
  • Symptomatic ARIA-E occurred in 2% of participants, and symptomatic ARIA-H occurred in 0.8% of patients.
  • Leqembi is approved in 48 countries and is under regulatory review in 10 countries.

Sources:

  • European Medicines Agency Summary of Product Characteristics (SmPC)
  • van Dyck, C.H., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21.
  • Morris, J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993;43:2412-2414.
  • Pedrosa, H., et al. Functional evaluation distinguishes MCI patients from healthy elderly people--the ADCS/MCI/ADL scale. The Journal of Nutrition, Health and Aging. 2010;14(8):703--9.

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