The European Commission approves lecanemab for the treatment of early-stage Alzheimer's disease

The European Commission has authorized the marketing of lecanemab (Leqembi) for the treatment of people with early stages of Alzheimer's disease or mild cognitive impairment due to this pathology. With this approval, which follows the positive recommendation issued by the European Medicines Agency (EMA) in November 2024, the drug is allowed to be marketed in all Member States and the evaluation process for its integration into the various public health systems begins.

In Spain, the Spanish Agency for Medicines and Health Products (AEMPS) will be responsible for establishing the conditions for financing and using the drug within the National Health System. This process involves assessing its cost-effectiveness, establishing access criteria, and defining procedures for diagnosing and monitoring patients who are candidates for treatment.

In this sense, Arcadi Navarro, Director of the Pasqual Maragall Foundation and the Barcelonaβeta Brain Research Centre, the Foundation's research centre, stresses that “We have passed a test, however, the real challenge begins now: the inclusion of the drug in national health systems. This administrative process is crucial, but it can and should be accelerated. Spain must make the negotiation and commercialization of the treatment a priority. We cannot fail: reducing the time between approval and actual availability is not only a strategic objective, but also a matter of social and healthcare responsibility.”

Lecanemab, the first disease-modiyfing treatent for Alzheimer's

Lecanemab is the first drug approved in Europe that modifies the course of Alzheimer's by acting directly on its pathophysiology, specifically, by reducing beta-amyloid deposits in the brain. Its use is indicated exclusively for patients with confirmed presence of this protein and in very early stages of the disease. It is also indicated for patients with one or no copies of the ApoE4 gene, who are at lower risk of amyloid-related abnormalities (ARIA), a side effect that involves swelling or small hemorrhages in the brain.

This decision marks significant progress, until now, available treatments has focused primarily on alleviating symptoms, without addressing the underlying mechanisms of cognitive decline. Clinical trials have shown that lecanemab can slow the progression of early-stage cognitive decline in 27%, which could translate into improved quality of life for patients and their families.

This approval is a key step in the advancement of treatments that target the biological mechanisms of Alzheimer's disease. Proper implementation in the National Health System is crucial, requiring sustained investment in early diagnosis and access to biomarkers.