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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…
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