The European Medicines Agency's Assessment of Lecanemab and Donanemab for Alzheimer’s Disease

This article examines the European Medicines Agency’s recent evaluation and approval of lecanemab and donanemab, the first monoclonal antibodies authorized in the EU to slow early Alzheimer’s disease. While these therapies demonstrate a statistically significant reduction in cognitive decline, the authors highlight a complex benefit-risk assessment due to modest clinical effects and serious safety concerns like amyloid-related imaging abnormalities (ARIA). To mitigate these risks, the EMA restricted the drugs to specific patient subgroups and mandated strict MRI monitoring protocols. The text details the regulatory journey from initial rejection to approval, emphasizing that while these treatments are not cures, they represent a pivotal shift in dementia care. Ultimately, the sources stress the importance of real-world evidence and future research to refine treatment safety and explore new therapeutic targets beyond the amyloid hypothesis.