After two decades without active treatments and so many disappointed hopes, 2024 was finally shaping up to be the year of Alzheimer's with the promise of the marketing of a new molecule, reserved for beginner or mild forms.
Hopes were all the greater since lecanemab, produced by the Eisai and Biogen laboratories and marketed under the name Leqembian, had already obtained the green light in the United States, Japan and Israel.
The key to this progress: better knowledge of the central role played by the amyloid protein in the disease. “The mechanism of this anti-amyloid monoclonal antibody is to neutralize the amyloid protein present in the brain by attaching to it and then cleaning it. The symptomatic effects are not immediate. The mechanism acts over timethen explained Professor Mathieu Ceccaldi, neurologist at Assistance publique – Hôpitaux de Marseille (AP-HM) and head of the Paca Ouest regional Alzheimer's Memory Expert Center.
But in the summer the European Medicines Agency (EMA) put an end to this wait by issuing a marketing refusal in the EU. A decision motivated by a “serious risk of side effects associated with this medication, particularly the frequent occurrence of hemorrhages and cerebral edema in patients“.
“The benefits outweigh the risks”
This week, the Agency reversed its position. “A review concluded that the benefits outweigh the risks in a limited patient population“, she justified.
For Professor Cecaldi, it is a “very important decision, very reasonable and responsible. This authorization reconciles a major evolution in the concept of care for Alzheimer's disease because it materializes this time, for good, an undeniable therapeutic advance while having the concern to limit the risk of side effects.”
However, this medication will only be reserved for patients at the beginning of the illness. “It won't heal. It slows the progression of the disease. After 18 months of treatment, we gain approximately 4 months. Likewise, its use will not be without constraints or the risk of adverse events. But its availability would allow eligible patients who wish to act on the cognitive decline that affects them to access a personalized assessment of their benefit-risk ratio which will be based on a carefully considered decision, medically documented and shared with those interested.“, continues the specialist.
But the story is not yet over. “The authorities of each country (the HAS for France, Editor’s note) will in turn rule on the medical benefit rendered and on the way of implementing this treatment in our healthcare systemprocrastinates Professor Ceccaldi. The duty of specialists is therefore now to prepare without delay and very seriously for its arrival and very probably in the years to come for that of other treatments acting on the mechanisms of Alzheimer's disease. This is a major issue.“
