Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab - PubMed
2 hours ago
- #Alzheimer's disease
- #EMA approvals
- #Dementia
- Alzheimer's disease (AD) is the leading cause of dementia in Europe with limited therapeutic options.
- Recent EU approvals of lecanemab and donanemab mark a significant milestone in AD treatment.
- Both drugs, based on the amyloid hypothesis, showed statistically significant effects on cognitive and functional outcomes in early AD patients.
- Clinical meaningfulness of these effects is still debated, and safety concerns like amyloid-related imaging abnormalities (ARIA) exist.
- The European Medicines Agency (EMA) assessed efficacy and implemented measures for safe use.
- These therapies do not halt disease progression but represent progress toward more transformative treatments.
- Future research should focus on refining patient selection, optimizing monitoring, and exploring combination therapies and new targets.