On January 6, 2023, the Food and Drug Administration (FDA) in the United States approved lecanemabthe second treatment of Alzheimer’s disease intended to attack the root of the disease and the slow cognitive decline that results from it. Researchers welcome the move, but their enthusiasm is clouded by reports of patient deaths and the fact that the FDA acted improperly last year when approving the first drug of its kind.
“This is very good news that gives hope to patients, and especially in the United States where sick people will have a new treatment alternative. Indeed, current treatments mainly have an effect on symptoms. This is the first time that such clinical effects have been observed in the case of a treatment for Alzheimer’s disease”, says Dr. Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation.
Lecanemab and indications: for which patients is it recommended?
THE lecanemab will be marketed as Leqembi. This anti-Alzheimer’s drug can be administered to patients with mild cognitive impairment or suffering from mild-stage Alzheimer’s disease. Patients should also have had tests confirming the presence of cerebral amyloid plaques.
How does lecanemab work?
The drug, a monoclonal antibody, is infused intravenously into the patient, before reaching their brain where it eliminates amyloid plaques, believed to cause cognitive impairment and dementia in Alzheimer’s disease.
Is lecanemab effective against Alzheimer’s disease?
Remember that for the time being the treatment of Alzheimer’s disease is essentially non-medicinal and that no curative drug can cure the pathology. But research is very active and many drugs are in development.
THE lecanemab is the first treatment for Alzheimer’s disease : it has been demonstrated that it slowed cognitive decline by 27% in a robust clinical trial (1795 participants with early Alzheimer’s disease) whose results have been published in the review NEJM in November 2022. It is manufactured by the biopharmaceutical companies Eisai in Tokyo (Japan) and Biogen in Cambridge, Massachusetts (USA).
What side effects?
However, these encouraging results have sometimes been accompanied by serious adverse effects. These most common “adverse events” were reactions to intravenous infusions, brain swelling or brain bleeding called amyloid-related imaging abnormalities, or ARIA.
“In people with early-stage Alzheimer’s disease, lecanemab reduced brain amyloid levels and was associated with less decline in clinical measures of cognition and function than placebo at 18 months, but was associated with adverse events”, conclude the researchers, who evaluated this drug. Before specifying: “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”
Two months later, the FDA made the decision to authorize this treatment, which was deemed “promising”.
“This decision was made quickly.writes the Fondation Vaincre Alzheimer in a press release, released in early January. 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 drug tested 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 of cognitive decline”. explains Dr. Maï Panchal.
THE lecanumab will therefore be the subject of a recommendation of heightened alertness regarding the occurrence of side effects. “Indeed, this treatment can induce side effects such as micro-haemorrhages or cerebral edema called ARIAcommented in a press release, Dr. Marion Levy, Head of Studies and Research at the Vaincre Alzheimer Foundation. They are, in the majority of cases, controllable and without serious consequences, but they must be monitored with regular MRI sessions”.
When will it be authorized in Europe and in France?
The Eisai and Biogen laboratories also wish to file a marketing application in Europe, but 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 Medicines Agency (ANSM).
In the USA, his price is estimated between $8,500 and $20,600 per year for patients.
Sources:
- Lecanemab in Early Alzheimer’s DiseaseThe New England journal of medicine, November 2022
- FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment, January 6, 2023.
- Lecanemab soon on sale in the United States, Fondation Vaincre Alzheimer, January 2023.
