The European Medicines Agency (EMA) has revised its decision to refuse approval of Alzheimer's disease drug Lecanemab and recommended approval of the drug. Switzerland has not yet received approval.
Bruno Nellwolf/ch media
Alzheimer's drug Lecanemab can help in the early stages of the disease.Image: Adobe Stock
There is some hope in the new Alzheimer's drug Lecanemab. In the United States, the drug was approved by the U.S. Food and Drug Administration (FDA) in June 2023. However, the European Medicines Agency (EMA) rejected approval from pharmaceutical companies Eisai and Biogen in July. The EMA has now revised its negative decision and recommended the drug, produced in Switzerland, to the European Commission for approval.
Lecanemab is a monoclonal antibody that works in the human body through passive immunity. The active ingredient targets protein deposits in the brain that are characteristic of Alzheimer's disease. According to current research, this beta-amyloid protein is one of two proteins whose aggregation and deposition are one of the possible causes of Alzheimer's disease.
Why did the EMA make a different decision? “Through the appeal, the company submitted new data that now cover a longer observation period. Three years instead of 18 months,” said Ansgar Verbeck, an Alzheimer's expert and former chairman of the Swiss Memory Clinic. Felbecker said. During this period, the positive effects of the drug increase. “Additionally, real-world data from the United States and other countries suggest that the incidence of side effects in real life is even lower than in studies.” Possible side effects of Lecanemab (sold under the brand name Leqembi) include brain swelling or microbleeds. Felbecker suspects these two reasons led to the change in the EMA's decision.
The neurologist thought the decision was the right one. “The data shows that this therapy is effective in the early stages of Alzheimer’s disease.” Otherwise, the European Medicines Agency would be almost the only country in the world to take a negative decision, along with Australia and Australia. That would disappoint Felbeck.
Felbeck believed that restrictions were correct
Approval is subject to certain restrictions. This drug should not be used in patients taking serious blood thinners or in patients who carry the APOE4 gene. “This restriction is correct and shows that the EMA wants to focus on avoiding serious side effects,” said Ansgar Felbecker.
The active ingredient, Lecanemab, is a monoclonal antibody sold under the trade name Leqembi.Image: Imagery
In June 2023, an approval application was also submitted to Swissmedic, the Swiss Medicines Agency. Alzheimer's disease experts would welcome it if Swissmedic made the same decision as the EMA. Alzheimer's patients in Switzerland must therefore continue to wait for Swissmedic's decision. The drug costs about $26,500 per year in the United States. While it only slightly improves symptoms, if started in the early stages it can improve the course of the disease. (bzbasel.ch)
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