A recently published letter in The Lancet, signed by Dr. Juan Fortea and leading European experts in Alzheimer’s disease, celebrates the European Commission’s approval of lecanemab as a key milestone in transforming the diagnostic and therapeutic approach to the disease. The authors highlight that this decision finally enables a long-awaited paradigm shift in Europe: moving from symptom-based diagnosis in later stages to early biological diagnosis, opening the door to more precise, personalized, and effective care.
This advance, they emphasize, will benefit not only those who receive treatment with lecanemab, but also a much larger number of people with cognitive impairment, by fostering structural improvements in diagnostic, prognostic, and clinical follow-up systems. The introduction of this treatment requires a reorganization of care that may have broad positive effects beyond the drug itself.
However, the letter also delivers strong criticism of the European regulatory process. The authors express disappointment that the European Medicines Agency (EMA) has rejected the approval of donanemab, despite the scientific evidence and the fact that this treatment is already being used in many other countries around the world. This decision, along with the accumulated delays in the process, has led to a nearly two-year setback in access to disease-modifying therapies in Europe, with direct consequences for patients and their families.
The signatories call for deep reflection on the consistency and agility of regulatory evaluation processes in Europe and urge greater openness to emerging data and a more flexible, nuanced assessment of risk-benefit ratios that allows for informed decisions based on the most up-to-date evidence.
The letter concludes with a clear message: while regulatory caution is necessary, so too is therapeutic urgency in the face of a progressive and fatal disease like Alzheimer’s. Europe cannot afford to continue falling behind.
Fortea J, Boban M, Engelborghs S, Frederiksen KS, Hort J, Kennelly S, Kramberger MG, Mehrabian S, Plantone D, Paquet C, Santana I, Scarmeas N, Solje E, Spiru L, Šutovský S, Vijverberg EGB, Winblad B, Jessen F. Regulatory asymmetry in Alzheimer’s disease care. Lancet. 2025. https://doi.org/10.1016/s0140-6736(25)00907-9.
