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Dr Gérald Kierzek (Medical Director of Doctissimo)
After initially blocking it last July, the European Medicines Agency finally authorized Leqembi this Thursday, November 14. This treatment will be prescribed for patients affected at an early stage of Alzheimer’s disease.
After blocking Leqembi (lecanemab) last July, the European Medicines Agency reversed its decision on November 14. This treatment intended to reduce the cognitive decline of patients affected by Alzheimer’s is finally authorized by the European regulator.
A recommended treatment for patients in the early stages of the disease
In its press release, the European body gives more details. “After reviewing its initial opinion, the EMA Committee for Medicinal Products for Human Use has recommended granting marketing authorization for Leqembi for the treatment of mild cognitive impairment. [troubles de la mémoire et de la pensée] or mild dementia due to Alzheimer’s disease. can we read.
“A review concluded that the benefits outweigh the risks in a limited patient population“. A surprising development following the initial decision issued in July, which considered that the observed effect of the treatment did not outweigh the risk of serious side effects, including potential bleeding in the brain.
A treatment already authorized elsewhere in the world
Leqembi was developed by the Japanese pharmaceutical laboratory Eisai with the American manufacturer Biogen. It is also marketed in the land of the rising sun, just as in China. In the United States, it was authorized in January 2023 for patients who have not reached an advanced stage of the disease. And the British drug regulator also approved this treatment last August.
In Europe, the EMA therefore authorizes the drug for patients with a lower risk of potential brain hemorrhage, i.e. those who have only one or no copies of the ApoE4 gene, a known type of gene as an important risk factor for Alzheimer’s disease.
In clinical trials conducted, Leqembi was administered intravenously once every two weeks. The treatment helped reduce the amyloid plaques that form around patients’ neurons.
A reduction in cognitive decline of 27% after 18 months of treatment
Asked about this treatment, Dr Gérald Kierzek believes that it can improve the condition of certain patients. “This monoclonal antibody is a new drug that targets amyloid plaques in the brain, one of the main pathological hallmarks of Alzheimer’s disease. the doctor begins. “Clinical trials have shown that Leqembi can slow cognitive decline in early-stage Alzheimer’s patients with:
- A 27% reduction in cognitive decline after 18 months of treatment compared to placebo;
- Beneficial effects persist even after stopping treatment for a period of 9 to 59 months”.
However, the doctor remains cautious. “The Leqembi is intended for patients suffering from Alzheimer’s disease at an early stage or presenting cognitive disorders light. It is a hope for the treatment of Alzheimer’s disease, but for each patient, the benefit-risk ratio must be evaluated, knowing that the effectiveness remains moderate and the potential side effects significant.“.
For Dr Gérald Kierzek, we must not forget another important aspect: “Early detection remains the essential step to treat patients as early as possible.”
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