This is a positive step forward that should be welcomed as a relief by patients in the early stages of Alzheimer’s disease. The European Medicines Agency (EMA) approved this Thursday, November 14, Leqembi (lecanemab), a very promising drug against this pathology. Welcome news for patients and their loved ones.
However, the file was poorly off to a good start. Let’s rewind a little: last July, the EMA opposed the marketing in Europe of this drug considered to be the first relatively effective in patients at an early stage of Alzheimer’s disease.
The result of 25 years of research, Leqembi is favored by the scientific community because it “cleans” the deposits of the beta-amyloid protein, which causes the formation of amyloid plaques. In a brain affected by Alzheimer’s, these plaques aggregate around neurons and prevent them from functioning properly.
A drug that slows the symptoms of the disease by almost 30%
Leqembi acts by slowing down the symptoms of the disease (such as memory loss, decline in judgment, or even the ability to find one’s way in space). Thanks to its targeted action on amyloid deposits, Leqembi manages to “slow cognitive decline by 27%“, specifies the Vaincre Alzheimer Foundation in a press release.
A risk of cerebral hemorrhage in certain patients
Given its effects, we understand better why Leqembi is awaited by patients and the scientific community. There remains one downside: this medication can be accompanied by serious side effects in certain patients, causing brain hemorrhages in some. It is this risk of complications which caused the refusal of the European Medicines Agency last July.
Treatment reserved for patients with a certain genetic heritage
So why this change of heart from the European health authority? After reassessment, the EMA affirms that the benefit-risk balance leans more in favor of the effectiveness of the treatment, which outweighs the adverse effects.
However, this marketing authorization remains subject to conditions. First, it concerns Alzheimer’s patients at an early stage who do not carry the apolipoprotein E4 gene. This gene constitutes an important genetic risk factor for developing Alzheimer’s disease. “This will restrict the number of patients a little but it is a necessary control because it is these patients who are most exposed to side effects”, estimates to Notre Temps Professor Bruno Dubois, director of the Institute of memory and Alzheimer’s disease (IM2A) at the Pitié-Salpêtrière hospital in Paris and member of the National Academy of Medicine.
Leqembi: the conditions set by the European Medicines Agency
The administration of treatment for the patients concerned must be strictly supervised, further demands the European Medicines Agency. The Vaincre Alzheimer Foundation details the EMA’s recommendations in a press release: “The treatment will be available in the form of a solution. The infusions will be administered by qualified healthcare professionals, trained to monitor, recognize and manage infusion-related reactions. Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of Alzheimer’s disease, with rapid access to magnetic resonance imaging (MRI).”
Patients will be subject to rigorous medical monitoring, adds Professor Dubois, also co-founder of the Alzheimer Research Foundation. “We will have to supervise the patients very closely, who will be monitored by very regular MRI scans to check that there are no contraindications. We are aware that we are entering into a complex system but things are progressing” .
A first step before the evaluation of the High Authority of Health
Another reason not to rejoice too quickly, this positive opinion from the EMA does not mean immediate availability of Leqembi in France. “This success marks a major step, but early access in France remains to be validated by the High Authority of Health,” puts the Vaincre Alzheimer Foundation into perspective. “Leqembi having received a positive opinion for marketing authorization, the pharmaceutical laboratory Eisai (at the origin of the re-evaluation of Leqembi) will now make a request for early access to the High Authority of Health (HAS )”, explains the Foundation.
This procedure makes it possible to make the drug available to patients as early as possible, when patients find themselves at a therapeutic impasse, which is the case in Alzheimer’s disease. “The HAS will then evaluate the clinical benefit and the progress brought by the drug and will determine whether the drug should be reimbursable and at what price,” the press release further specifies.
Finally, the drug must obtain approval from the National Agency for the Safety of Medicines and Health Products (ANSM) to be marketed in France and be accessible to patients.
A positive signal that “opens the way” to new treatments
The European Medicines Agency’s agreement on Leqembi constitutes a mixed victory. This first step sends an encouraging sign to the scientific and medical community and augurs new perspectives, according to Professor Bruno Dubois. “We feel a certain satisfaction for our patients and our status as doctors and researchers. It is important to be able to work on this drug, to see what it brings to patients, to better understand its indications, its limits. This is the start of something.”
The neurologist, however, remains cautious and tempers the scope of the upcoming accessibility of the Leqembi. “This is a signal that is both exciting and disappointing. Exciting because it opens the way to new treatments against Alzheimer’s disease but also disappointing because the effect remains modest.” Because the doctor sees fit to point out: Leqembi is not a miracle drug capable of curing the disease. “We have a relatively effective treatment which slows down the progression of symptoms a little. [en les retardant de six mois en moyenne]. This moderate effect does not block the worsening of the disease but ensures that the patient’s condition worsens less quickly.
The fight against Alzheimer’s disease is therefore still far from won while nearly 10 million new cases are diagnosed each year, according to the Pasteur Institute.
Sources
Thanks to Professor Bruno Dubois, director of the Institute of Memory and Alzheimer’s Disease (IM2A) at the Pitié-Salpêtrière hospital in Paris and member of the National Academy of Medicine, co-founder of the Foundation for Alzheimer Research.
CP of November 15, 2024 from the Vaincre Alzheimer Foundation
https://www.pasteur.fr/fr/centre-medical/fiches-maladies/alzheimer-maladie
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