The European Commission authorizes the marketing of donanemab for the treatment of early-stage Alzheimer’s

The European Commission has granted marketing authorization for the anti-amyloid drug donanemab for the treatment of symptomatic early-stage Alzheimer’s disease (mild cognitive impairment or mild dementia) in adults with confirmed amyloid pathology. This authorization represents a significant step forward in the fight against the disease, which affects between 830,000 and 900,000 families in Spain.

The Commission’s decision comes after a re-evaluation process by the European Medicines Agency (EMA), which reviewed new data on the drug’s safety profile, particularly concerning amyloid-related imaging abnormalities (ARIA). The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits outweigh the risks in a restricted patient population—specifically those with one or no copies of the APOE4 gene—and recommended specific safety measures to minimize the risk of ARIA.

"From the Pasqual Maragall Foundation and the BBRC, we welcome the European Commission’s decision to authorize the marketing of donanemab for the treatment of early-stage Alzheimer’s disease in people with confirmed amyloid pathology. This authorization represents a relevant step forward in the fight against the disease, at a time when each advance brings new hope to those affected and their families", explains Dr. Arcadi Navarro, Director of the Pasqual Maragall Foundation and the Barcelonaβeta Brain Research Center. 

The national evaluation phase now begins, in which the competent authorities will determine the conditions for access and reimbursement of the treatment.

"We celebrate this regulatory milestone, but we also wish to highlight that the real availability of the treatment will depend on national-level decisions regarding its assessment, funding, and access. In this regard, we advocate for a rigorous, equitable, and evidence-based implementation, ensuring that any new treatment reaches the patients who can benefit from it in a safe and fair manner. This authorization is also a reminder of the importance of research as a pathway to transforming the future of Alzheimer’s. At the Pasqual Maragall Foundation, we will continue working, through research and social awareness, to move closer to a world free of this disease", concluded Dr. Arcadi Navarro.