The Commission has today granted EU authorisation for a medicine to treat mild cognitive impairment in the early stages of Alzheimer’s disease, under strict conditions.
It is for use in people who have only 1 or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain. It is the first such medicine to be authorised in the EU.
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, today’s authorisation decision also sets strict conditions on the use of Leqembi, as well as clear risk mitigation requirements.
More information will soon be available in the Union Register of Medicinal Products.
