On Wednesday 16 April, the European Commission announced that the previous day it had granted EU authorisation for Leqembi, a drug designed to treat mild cognitive impairment in the early stages of Alzheimer's disease.
Strict conditions have been laid down for the first drug of this type to be authorised in the European Union. However, this drug will only be available for a very specific category of Alzheimer’s patients, who are far from a majority.
The European Medicines Agency (EMA) initially issued a negative opinion on its marketing in Europe, considering that the expected benefits did not outweigh the identified risks. In November 2024, it changed its mind, issuing a positive opinion (https://aeur.eu/f/gfo ) for the marketing of this product for the treatment of a specific type of patient: those with mild cognitive impairment or mild dementia linked to early Alzheimer's disease, and who have only one or no copy of the ApoE4 gene. This medicine is intended for people who also have amyloid beta plaques in the brain. (Original version in French by Lionel Changeur)