2024-09-30 08:00:10
Neurodegenerative diseases, including Alzheimer’s disease, affect more people worldwide than cancer. Health systems are not prepared for the threefold increase in the number of cases by 2050. Significant progress has been made in recent years to diagnose Alzheimer’s disease earlier, thanks to new biomarkers, including including blood tests. Additionally, lifestyle changes have shown promise in preventing dementia. Much of this pioneering work has been carried out in Europe, highlighting the important contributions of our researchers to solving this global problem.
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A few years ago, hope arose with treatments designed to remove amyloid deposits from the brain, a key component of Alzheimer’s disease. In two phase III clinical trials, these treatments not only reduced the number of amyloid plaques in the brains of treated patients, but also, for the first time, slowed the progression of the disease. This advance was welcomed by Alzheimer’s disease researchers and patient organizations, leading to approval of these drugs in the United States and other countries.
However, two months ago, the European Medicines Agency (EMA) decided not to approve lecanemab, the drug furthest along in the approval process for the European market. This decision highlights an important cultural difference in how risk and innovation are viewed in different countries. While Europe often takes a cautious approach, countries including the United States, China, South Korea, Japan and, more recently, the United Kingdom have approved the drug, giving patients and doctors the possibility of using it.
Manageable side effects
The EMA’s caution stems from the high incidence of side effects, such as increased risk of bleeding and brain edema. It is essential to remember that side effects are common with many new drugs, including those for cancer or AIDS. The decision to accept these risks should rest primarily with patients. The conservative position of the EMA has the consequence that European patients and doctors, wishing to obtain a treatment whose effectiveness is proven, are refused this access.
At recent international conferences, such as the one in Tokyo on September 18 and 19, colleagues from countries where the drug has been approved have shown that the side effects are manageable. They also noted significant benefits for some patients. Although these results require further validation, it is encouraging that most of these side effects are only detectable by routinely performed MRI scans and have no lasting clinical impact.
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