Today, 15 April 2025, the European Commission has approved the use of lecanemab in the treatment of early Alzheimer’s disease, the first disease-modifying therapy for Alzheimer’s disease to be made available in the EU27 and EEA Member States.
This landmark approval follows the reaffirmed positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and subsequent review by the Commission’s Standing Committee on Medicinal Products for Human Use and the European Commissions’ Appeal Board which both returned a “no opinion” verdict.
Lecanemab is now the first therapy of its kind approved in the EU that can potentially slow the progression of Alzheimer’s disease. The use of lecanemab will now be considered by national payers, who will assess the treatment against further nationally determined criteria.
On their website, the European Commission said:
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.
Now that Europe has approved the first treatment, as have a growing number of countries around the world, it is vital that governments and health systems rapidly adapt their preparedness for diagnosis and treatment
ADI will continue to provide updates as and when they become available.
