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EMA Approves Alzheimer's Drug Leqembi

The European Medicines Agency approves Leqembi, a new Alzheimer's drug, with strict conditions to mitigate serious side effects.

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French

France

HealthEuropean UnionHealthcareTreatmentAlzheimer'sMedical ResearchDrug Approval

European Medicines Agency (Ema)Ap-Hp

Nicolas Villain

How will access to Leqembi be managed?: The drug will be available through a controlled access program to ensure it's used only in the recommended patient population. This program requires MRI monitoring for side effects before treatment and at specific intervals thereafter.
What is Leqembi and what is its purpose?: The European Medicines Agency (EMA) has approved Leqembi (lecanemab) to treat early-stage Alzheimer's disease. This monoclonal antibody targets beta-amyloid plaques in the brain, aiming to reduce cognitive decline.
What are the restrictions on Leqembi's use?: Leqembi's approval comes with restrictions. It's only for patients with mild cognitive impairment or mild dementia due to Alzheimer's and who do not have multiple copies of the ApoE4 gene, which increases the risk of brain bleeds. Patients must also undergo MRI scans to monitor for side effects.
Why did the EMA initially reject Leqembi, and what led to its approval?: The EMA initially rejected Leqembi due to concerns about serious side effects, including brain bleeding. However, further review of clinical trials showed benefits outweighed risks for a specific patient population, leading to conditional approval.
What is the estimated percentage of Alzheimer's patients in France who would qualify for Leqembi?: Neurologist Nicolas Villain believes that between 5% and 15% of Alzheimer's patients in France meet the criteria for Leqembi. The approval is considered positive news for eligible patients, offering a potential treatment option to slow disease progression.

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