Prime Highlights
- The European Commission of the EU has approved lecanemab (Leqembi), the first in the EU of an Alzheimer’s drug that targets the disease cause.
- The drug is only approved for early-stage patients with minimal genetic risk of severe side effects.
Key Facts
- Lecanemab is for early Alzheimer’s or mild cognitive impairment patients.
- It is only administered to patients who have zero or one copy of the ApoE4 gene due to safety concerns.
Key Background
The European Commission has authorized lecanemab, a pioneering Alzheimer’s drug targeting solely the underlying mechanism of the disease. On the market in the EU under the name “Leqembi,” the medicine was created by Japanese drug company Eisai and US biotech company Biogen. It is currently an Alzheimer’s breakthrough, with the medicine predicted to not only slow symptoms but slow disease progression by attacking amyloid beta brain plaques.
Lecanemab has been licensed for use in people with early-stage Alzheimer’s, people with mild cognitive impairment or mild dementia. Its efficacy was determined by clinical trials that measured a modest but measurable slowdown in mind loss over a period of treatment that lasted 18 months. But the drug is not safe. It has previously been rejected by the European Medicines Agency (EMA) in 2024 due to concerns of side effects including swelling and brain bleeding in patients with two copies of the ApoE4 gene.
When rethought, the EMA allowed a subgroup – those who carry none or one copy of the ApoE4 gene. These have been reported to be less prone to suffer from side effects. However, patients treated with lecanemab must be administered bi-weekly intravenous infusion and repeated brain MRI to protect their safety and thus might deter widespread use.
The medication is not a cure and acts only on patients who are in the initial stage of the disease. Despite its limitation, the approval is a milestone for the EU in Alzheimer’s treatment. Lecanemab was previously approved in the US, Japan, and the UK, although cost-effectiveness limited its use in certain regions. The European approval may pave the way for more research on disease-altering treatments for Alzheimer’s.
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