Lecanemab is marketed under the name Leqembi.Image: www.imago-images.de
European health authorities have reversed their refusal to authorize lecanemab, a drug against Alzheimer’s disease, and are recommending its authorization. In Switzerland, its deployment is not yet in sight.
Bruno Knellwolf / ch media
There is much hope for the new Alzheimer’s drug, lecanemab. In the United States, it received approval from health authorities already in June 2023. On the other hand, the European Medicines Agency (EMA) initially refused to approve it in July. But the EMA has just revised its decision and recommended that the European Commission authorize lecanemab, which is produced in Switzerland.
Lecanemab is a monoclonal antibody that acts by passive immunization in the human body. The active ingredient targets the accumulations of proteins characteristic of Alzheimer’s disease in the brain. This beta-amyloid is one of two protein substances whose agglutination and deposition are among the possible causes of Alzheimer’s disease, according to current research.
Why did the EMA change its mind? “The company presented new data in its appeal, now including a longer observation period, three years instead of 18 months,” explains Ansgar Felbecker, specialist in Alzheimer’s disease and former president of Swiss Memory. Clinics. During this period, the positive effects of the drug became stronger.
“Moreover, real-world data from the United States and other countries show that the rates of side effects in reality are even lower than those observed in studies.”
Ansgar Felbecker
Possible side effects of lecanemab, marketed as Leqembi, include brain swelling or microhemorrhages.
Ansgar Felbecker believes that the EMA’s decision is the right one. “Data indicate that this treatment is effective in the early stages of Alzheimer’s disease.” If the EMA had not changed its mind, it would have found itself almost alone in the world with Australia. What the neurologist would have found “disappointing”.
And in Switzerland?
Permission was granted with certain restrictions. The medicine cannot be given to patients on strong anticoagulation or to those who carry the APOE4 gene. Ansgar Felbecker specifies:
“This restriction is fair and shows that the EMA wants to focus on preventing serious side effects”
Ansgar Felbecker
In June 2023, an application for authorization was also submitted to Swissmedic, the Swiss authority for therapeutic products. Ansgar Felbecker would appreciate Swissmedic making the same decision as the EMA, but, for now, Alzheimer’s patients in Switzerland must continue to wait for its decision.
The drug costs around $26,500 per year in the United States. It only slightly improves symptoms, but can delay the progression of the disease when it starts at an early stage.
Translated and adapted by Noëline Flippe
