The Vaincre Alzheimer Foundation is delighted with this decision, which has actively advocated for access to this innovation. And the foundation emphasizes that this “ success marks a major step, but early access in France remains to be validated by the High Authority of Health.
As the treatment is reserved for a limited population of Alzheimer’s patients, the Foundation calls for continued efforts to support medical research, in order to develop new treatments and guarantee early diagnosis for all patients.
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Flashback: it was November 2022, the first results on the effects of Leqembi® had just been released.
And today, at the end of 2024, the AEM has just given a positive opinion for its marketing authorization. Indeed, following a first refusal last July, the EISAI laboratories (which manufacture this molecule) requested a re-evaluation of Leqembi® by this same agency.
« After re-examining the file, Europe finally assessed that the relationship between the benefit provided by the drug and the risk was favorable for a specific population of Alzheimer’s patients. » underlines the press release from the Vaincre Alzheimer Foundation.
This good news comes after the drug was authorized in the United States and Japan last year, then in China, South Korea, Hong Kong, Israel and the United Kingdom this year.
However, it should be noted that Leqembi® only concerns early-stage Alzheimer’s patients who do not carry the apolipoprotein E4 gene.
This apolipoprotein E4 gene is the major genetic risk factor for Alzheimer’s disease and it influences the appearance of significant side effects when the patient is under treatment.
This treatment will be available as a solution. Infusions will be administered by healthcare professionals trained to monitor, recognize and manage infusion-related reactions. Treatment should be initiated and supervised by doctors experienced in the diagnosis and treatment of Alzheimer’s disease, with rapid access to magnetic resonance imaging (MRI).
While the molecule has finally received a positive opinion for marketing authorization, the Eisai Pharmaceutical Laboratory must now make a request for early access to the High Authority of Health (HAS).
Let us point out that early access is a way of making the drug accessible to patients as early as possible, particularly when the drug is intended for patients in 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.
Leqembi® is an anti-amyloid immunotherapy (lecanemab antibody) whose aim is to clean amyloid deposits in the brain of patients with mild cognitive impairment or early-stage Alzheimer’s patients.
After 18 months of treatment, this drug showed a slowing of cognitive decline by 27%. These cognitive and functional performances were assessed on memory, orientation, judgment and problem solving, social activities, home and leisure, and self-care.
Even if Europe has favorably assessed the benefit/risk balance of the treatment, side effects exist. Among the main ones, we note “ARIA” which are cerebral hemorrhages and edemas observed by MRI, due to the significant elimination of amyloid deposits by the cerebral vessels.
Although most of the time they are controllable and without serious consequences for patients, these side effects can be more serious in rare cases. This is why it is important to maintain monitoring with regular MRI sessions throughout the treatment.
« A first step has been taken. Still others await us, but this therapeutic turning point is a real hope for patients. Let’s continue to beat Alzheimer’s together! » declared Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation.
