Alzheimer’s: Lecanemab approved in Europe for the treatment of early-stage disease

Publication date: 06-06-2025
Updated on: 06-06-2025
Topic: Neurology
Estimated reading time: 1 min
Following a complex regulatory process, on April 15, 2025, the European Commission approved lecanemab, marketed as Leqembi®, for the treatment of early-stage Alzheimer’s disease. This makes it the first anti-amyloid monoclonal antibody approved in the European Union for this specific indication.
The approved indication covers adult patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease, regardless of ApoE4 gene status, with confirmed amyloid positivity (via PET imaging or cerebrospinal fluid analysis).
The drug approval process
Lecanemab’s path to approval in Europe was not straightforward. In July 2024, the CHMP (Committee for Medicinal Products for Human Use of the EMA) initially issued a negative opinion. However, following an appeal by the manufacturer Eisai, supported by additional efficacy and safety data, the CHMP reassessed the documentation and issued a positive opinion in November 2024. This opinion was upheld in early 2025, leading to formal authorization by the European Commission.
San Raffaele: first Italian center to administer Lecanemab since 2024
IRCCS Ospedale San Raffaele in Milan, through its Center for Alzheimer’s Disease and Related Disorders (CARD), directed by Professor Massimo Filippi, Head of the Neurology Unit, Neurophysiology Service, and Neurorehabilitation Unit, and Full Professor of Neurology at Vita-Salute San Raffaele University, began administering lecanemab as early as September 2024. This was made possible under the Italian Ministerial Decree of February 11, 1997, which allows controlled therapeutic use of drugs undergoing regulatory evaluation.
“The European approval of lecanemab represents a significant step forward in the fight against Alzheimer’s disease,” says Professor Filippi. “Our center is committed to ensuring safe and timely access to these new therapies through a structured approach that includes early biological diagnosis, risk factor assessment, and ongoing monitoring of treatment efficacy and safety.”
In Italy, the drug is currently under review by the Italian Medicines Agency (AIFA), which will define the criteria for prescription and reimbursement. In the meantime, IRCCS Ospedale San Raffaele continues to offer this innovative therapy to eligible patients, contributing to the advancement of Alzheimer’s disease management in the country.