Brussels, 17 April 2025
The EU Commission granted EU authorisation for Leqembi, a medicine to treat mild cognitive impairment in the early stages of Alzheimer’s disease, under strict conditions. It is the first such medicine to be authorised in the EU.
This medicine is for use in people who have only one or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain.
The authorisation is based on the positive scientific assessment of the European Medicines Agency, which concluded that the benefits of this medicine outweighed the risks, in a particular population of patients with such disease and as long as risk minimisation measures are applied. Therefore, the authorisation decision also sets strict conditions on the use of Leqembi, as well as clear risk mitigation requirements.
Source – EU Commission