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First disease-modifying drug Leqembi now approved for the treatment of early Alzheimer's disease in Europe

April 16, 2025

On 15th of April, the European Commission granted EU‑wide marketing authorisation for Leqembi (lecanemab), the first medicine in Europe that targets the disease process underlying Alzheimer’s rather than simply easing its symptoms. The decision follows the European Medicines Agency’s positive opinion last November and takes immediate effect across all EU and EEA countries. 

What does this mean? 
This is big news as Leqembi becomes the first approved so-called disease-modifying treatment for early-stage Alzheimer's disease in Europe – a significant step forward for the more than 160 000 people in Sweden and the millions more across Europe who live with the condition. 

What is Leqembi? 
Lecanemab (Leqembi®) is an antibody given by intravenous infusion every two weeks. It binds to amyloid‑beta protein – a toxic protein that forms sticky plaques in the brains of people with Alzheimer’s, helping the body clear the plaques that gradually cause brain cell damage. By removing these plaques early in the disease progression, this treatment aims to preserve memory and thinking abilities for longer. In the clinical trial, individuals that were receiving this drug declined less in their memory functions than those who received placebo. 

As a side note, the science behind Leqembi began with research by Swedish professor Lars Lannfelt and colleagues at Uppsala University. 

Who can receive it – and why the restrictions? 
It is important to highlight that the treatment will only be provided for adults who are: 

  • In the very early stages of the disease (mild cognitive impairment and mild Alzheimer’s) 
  • Harbour amyloid-beta in the brain which is confirmed by a positive Positron Emission Tomography (PET) scan 
  • Carry one or no copies of ApoE4 gene.  

People with two copies of ApoE4 are excluded because they face a higher risk of amyloid‑related imaging abnormalities (ARIA) such as brain swelling or tiny bleeds on MRI scans. 

If you want to learn more about Leqembi, please read our previous article to gain more insights about the clinical evidence on the benefits and potential adverse effects.  

What happens next? 
From this moment on, each member state will make decisions regarding the funding and national reimbursement strategies of Leqembi. Health‑technology assessments and price negotiations will take time, so access is likely to differ across countries. Hospitals will also require additional resources for the infrastructure and training of staff, before the treatment can be rolled out. 

Further reading 

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