The observed effect of the treatment, marketed under the name Leqembi and authorized in the United States, “does not outweigh the risk of serious side effects,” according to the regulator.
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The European Medicines Agency (EMA) ruled on Friday 26 July against the marketing in the European Union of a highly anticipated treatment aimed at reducing cognitive decline in patients suffering from Alzheimer’s disease.
The observed effect of this treatment, marketed under the name Leqembi, and authorized in the United States, “does not outweigh the risk of serious side effects associated with the drug”according to a press release from the regulator, which notably highlights “Potential bleeding in patients’ brains”.
For decades, researchers have failed to make a real breakthrough in the fight against Alzheimer’s disease, which affects tens of millions of people worldwide. No cure exists to date. Leqembi was authorized in January 2023 by the American health authorities for patients who have not yet reached an advanced stage of this neurodegenerative disease, which leads to the progressive and irreversible loss of mental functions, particularly memory.
