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

The European Commission has granted the 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 in the fight against the disease which affects between 830,000 and 900,000 families in Spain.

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

"At the Pasqual Maragall Foundation, 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 disease. This authorization represents a significant step forward in the fight against the disease, at a time when every advance represents new hope for those affected and their families.", explains Dr Arcadi Navarro, director of the Pasqual Maragall Foundation and the Barcelonaβeta Brain Research Center.

Now the national evaluation phase begins, in which the responsible bodies must determine the conditions of access and reimbursement of the treatment.

"At the Foundation, we celebrate this regulatory advance, but we also want to emphasize that the actual availability of the treatment will depend on decisions made at the national level regarding its evaluation, funding, and access. In this sense, we are committed to a rigorous, equitable, and evidence-based implementation that ensures that any new treatment reaches the patients who can benefit safely and fairly. This authorization is also a reminder of the importance of research as a way to transform the future of Alzheimer's. At the Pasqual Maragall Foundation, we will continue working, through research and social awareness, to advance toward a world free of this disease., concludes Dr. Arcadi Navarro.