Why Did the European Medicines Agency Reject a Drug Slowing Down Alzheimer’s Disease
The European Medicines Agency (EMA) has announced its decision to reject the marketing authorization of the drug “Leqembi” for the treatment of Alzheimer’s disease, citing safety concerns and severe side effects. In a statement, the agency explained that the benefits of “Leqembi,” which was approved by the U.S. Food and Drug Administration in May 2023, do not outweigh the risk of serious adverse events, particularly the risk of brain bleeding.
The EMA highlighted that “Leqembi,” administered intravenously every two weeks, reduces the number of amyloid plaques, but clinical trials have shown a significant increase in amyloid-related abnormalities on medical imaging, including brain swelling and the risk of hemorrhage.
Japanese pharmaceutical company Eisai, which developed “Leqembi” in collaboration with the U.S. company Biogen, has stated that it will request a re-examination of the EMA’s decision.
It is worth noting that researchers have struggled for decades to make significant progress in the fight against Alzheimer’s disease, which affects tens of millions of people worldwide.
Approximately 8 million people in the European Union suffer from some form of dementia, and Alzheimer’s disease accounts for more than half of these cases. To date, no drug has been found to cure this disease.
