On January 6th, the United States health authority (FDA) authorized the marketing of lecanemab, a new anti-Alzheimer’s drug, the latest results of which were revealed last November. Finally an effective Alzheimer’s treatment on the market ? This is the question that everyone is asking when this agreement is announced.
The marketing of lecanemab under the name Leqembi
Based on the first published information, lecanemab will be marketed under the name Leqembi. It can be administered to patients with mild cognitive impairment or mild-stage Alzheimer’s disease. This is the same category of patients who received the treatment in the clinical trial. Patients should also have had tests confirming the presence of cerebral amyloid plaques. In addition, there will be a recommendation 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.“
Dr Marion LEVY, Head of Studies and Research at the Vaincre Alzheimer Foundation
A quick decision, less than a year after first positive results
This decision was made 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 6th, 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. […] This is very good news that gives hope to patients, and 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.“
Dr Maï PANCHAL, General and Scientific Director of the Vaincre Alzheimer Foundation
The Eisai and Biogen laboratories also wish to file a marketing application in Europe. However, the timetable is not yet known. 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 ).
The European market launch of this Alzheimer’s treatment soon?
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. 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. For 17 years, the Fondation Vaincre Alzheimer has played a key role in funding medical research in order to better understand the causes of the disease and identify new therapeutic approaches, thanks to its loyal donors, patrons and partners.
Published by the Editorial Staff on