The European Commission has granted approval for a new treatment for Alzheimer’s disease in its early stages, marking it as the first of its kind to receive authorization within the European Union.
The drug “Lecanemab,” a monoclonal antibody, targets the underlying process of the disease rather than just addressing its symptoms, allowing for a reduction and slowing of cognitive decline in patients.
This medication, which is also available in other countries (particularly the United States, where it is marketed under the name “Leqembi”), will only be accessible to a very specific group of Alzheimer’s patients that do not make up the majority.
Initially, the European Medicines Agency issued a negative opinion regarding its marketing in the European market, believing that the anticipated benefits did not outweigh the potential risks identified.
In November 2024, the agency finally issued a positive opinion for marketing this product for a specific group of patients: those experiencing mild cognitive disturbances or mild dementia associated with early Alzheimer’s, and who possess a single copy or do not have any copies of the “ApoE4” gene, which is a major risk factor for developing Alzheimer’s disease.
Patients in this category exhibited a lower likelihood of experiencing serious side effects during clinical trials, according to the European Medicines Agency.
The drug, which is administered intravenously every two weeks, will be marketed in the European market by the pharmaceutical company Eisai.
Alzheimer’s disease is responsible for 60 to 70 percent of dementia cases. According to the World Health Organization, approximately 55 million people globally suffer from dementia, including around 220,000 in Belgium.
