More specifically, lecanemab is a antibody that aims to “cleanse” the brain of amyloid plaquesthese famous toxic aggregates which have been talked about for years now, and which can be observed in the brains of patients suffering from Alzheimer’s.
For the first time, this treatment has shown a clearing of the brain of these amyloid plaques accompanied by a significant slowing of cognitive decline in treated patients, after 18 months of treatment.
Before taking this treatment, patients must have had tests confirming the presence of cerebral amyloid plaques. Additionally, there should be a rrecommendation for increased vigilance regarding the appearance of side effects.
« Indeed, this treatment can induce side effects such as micro-haemorrhages or cerebral edema called ARIA. They are, in the majority of cases, controllable and without serious consequences, but they must be monitored with regular MRI sessions. says Dr. Marion Levy, Head of Studies and Research at the Vaincre Alzheimer Foundation.
This decision concerning this new molecule was taken quickly. Indeed, the Japanese pharmaceutical laboratory Eisai, in collaboration with the American laboratory Biogen, submitted the file to the FDA in May 2022, at the end of the 2nd phase of the clinical trial. As a reminder, a clinical trial is generally done in 3 phases.
In July 2022, the FDA, in view of the results on amyloid plaques, then gave the dossier priority status. An accelerated procedure had therefore been initiated, leading to a decision on January 6, 2023, less than a year after the first positive results.
« This accelerated procedure is intended for diseases that have no treatment and therefore for which there is a real medical need. It can be applied if the tested drug shows signs of efficacy on the disease, thus making it possible to predict a clinical effect of the drug. In the case of lecanemab, the latter showed a strong reduction in the accumulation of cerebral amyloid plaques in Alzheimer’s patients and a slowing down of cognitive decline. explains Dr. Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation.
What about placing on the European market? The Eisai and Biogen laboratories will also file a marketing application in Europe. However, the calendar is not yet known to date..
Remember that for marketing in France, lecanemab must first obtain authorization from the European Medicines Agency, then that of the National Agency for the Safety of Medicines and Health Products (ANSM ).
« This is very good news that gives hope to patients, especially in the United States where sick people will have a new alternative treatment. Indeed, the current treatments have an effect mainly on the symptoms. This is the first time that such clinical effects have been observed in the case of a treatment for Alzheimer’s disease. adds Dr. Maï Panchal.
Hope now turns to future treatments that could be discovered in the next few years. This authorization is in fact the result of nearly 40 years of research since the discovery of the beta-amyloid protein in 1984, which causes amyloid plaques.
Another toxic protein, called tau, accumulates in the diseased brain and causes symptoms. Other factors come into play, such as neuro-inflammation, cellular metabolism, and vascular, genetic and environmental aspects. Indeed, Alzheimer’s disease is multifactorial.
Thus, in order to stop cognitive decline, it will be necessary to develop several treatments that target these different aspects…