Lecanemab has just been approved by the European Union. What promises for patients? What risks? And above all, when will it be accessible in France? We take stock.
LECANEMAB: An unprecedented mode of action
LECANEMAB, also known as Leqembi®, is a monoclonal antibody designed to slow the progression of Alzheimer’s disease. It acts by targeting the beta-amyloid protein plates that accumulate in the brain of the patients. Unlike symptomatic treatments, it aims at the alleged causes of the disease at a very early stage. But its profits are accompanied by notable risks, including brain micro-hemorrhages and edema. These undesirable effects, although infrequent, can be serious, especially in fragile or anticoagulant patients. Doctor Christophe de Jaeger, physiologist and True Medical expert, recalled in 2023 that: “The treatment does not work 100 % but slows down certain developments in the disease in certain patients“.
The LecaneMab finally benefited on April 15, 2025 from an authorization to marry European market by the European Medicines Agency. For their part, associations are delighted with the arrival of this drug already authorized in many countries including the United States. “”Lecanemab is finally authorized in Europe, and this is good news ! This treatment will be administered to a limited population for which The profit prevails over risks. These are people at the early stage of the disease. However, patients most at risk of complications will not be able to receive it ” Judge Doctor Rémy Genthon, scientific director of the Alzheimer Research Foundation.
A European marketing in several episodes
On July 26, 2024, the European Medicines Agency (EMA) rejected the demand for marketing of Leqembi (LecaneMab) for the early treatment of Alzheimer’s disease in Europe. Conversely, on July 3, the American authorities had approved its marketing. The EMA had justified its refusal by a limited impact on the scores of cognitive tests, potentially serious side effects, and an increased risk of complications for certain genetic variants, including APOE4. All the details of this decision and the reactions of associations are available in our article “Alzheimer’s: Europe blocks a highly anticipated and authorized treatment in the USA”.
In the United Kingdom, the National Health Service (NHS) expenditure control organization had also refused to reimburse this medication, saying that its profits were “relatively modest (…) which means that it cannot be considered as having good value for money“However, it remains available for patients for 20,000 pounds, or more than 23,000 euros.
It is ultimately only April 15, 2025 that the European Commission gave its green light, after a favorable opinion from the European Medicines Agency (EMA) in December last supported by new security data provided by the laboratory. This period is explained in particular by the Vigilance of European agencies vis-à-vis experimental treatments. The Lecanemab monitoring protocol is binding: administration by infusion every two weeks, regular MRI examinations, side effects …
LECANEMAB soon in France: for whom, and when?
The next step will be played in France, with the assessment by the High Authority for Health (HAS), which must rule on the medical service rendered and the conditions of prescription. The first patients could benefit from it at the end of 2025, provided they are followed in a specialized memory center. While waiting for discussions on the price of this treatment with health insurance, this European decision should allow the laboratory to request an early access procedure in France.
But this treatment will only be addressed to a very targeted population: people with very early signs of the disease, confirmed by organic tests and brain imaging. And we know that the diagnosis of Alzheimer’s disease is today largely undervalued, because of a weak therapeutic arsenal, diagnostic tools still too unconditionally accessible and a bad knowledge of the general public vis-à-vis this pathology …
“”The European Commission’s decision must now push the public authorities to do everything to promote early diagnosis “underlines the president of France Alzheimer and related diseases, Joël Jaouen. “”The more the disease is detected, the better care. And we must not forget sick people at a more advanced stage, for whom solutions must also be found or consolidated in the case of non -drug interventions, essential in the care path “.
Note that at the same time, the European Commission reiterated its refusal of marketing concerning another promising drug Donanemab. The Agency’s human use committee has considered that the benefits of the drug did not justify the risk of potentially fatal events.