The approval of lecanemab, a groundbreaking disease-modifying drug for Alzheimer’s disease, marks a major advancement over a century after the disease was first described. However, its access varies globally, with the drug approved in some regions and rejected in others, reflecting divisions within the medical community.
Lecanemab, a monoclonal antibody targeting amyloid-β (a protein linked to Alzheimer’s), was approved by the FDA in 2023 based on a trial showing a 27% reduction in cognitive decline in patients with early-stage Alzheimer’s. Regulatory approval followed in Japan, China, South Korea, and Israel. However, on July 26, 2024, the European Medicines Agency (EMA) refused approval, citing concerns that the benefits did not outweigh the risks, particularly due to amyloid-related imaging abnormalities (ARIA), which can range from mild to severe, even fatal in rare cases.
This divergence highlights the ongoing debate over the drug’s safety and efficacy, with regulators and clinicians needing to balance new advances against potential harms.1
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References
- Lancet, N. (2024). Divisions over lecanemab: keeping an open mind. The Lancet, 404(10458), 1077. https://doi.org/10.1016/s0140-6736(24)02075-0
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