2024-11-15 12:14:00
A woman suffering from Alzheimer’s disease, in a retirement home, October 18, 2016, in Saint-Quirin (Moselle). PATRICK HERTZOG / AFP
The European Medicines Agency (EMA) has finally approved a treatment aimed at reducing cognitive decline linked to early-stage Alzheimer’s disease. In July, the EMA issued a negative opinion on the use of lecanemab, marketed under the name Leqembi. Nearly a million people are affected by the disease in France, 35.6 million worldwide. Lecanemab is a monoclonal antibody (a type of protein) that attaches to a substance called beta-amyloid, which causes plaques that form in the brains of patients with Alzheimer’s disease. It thus aims to reduce these plaques.
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“The EMA Committee for Medicinal Products for Human Use recommended, Thursday, November 14, granting marketing authorization to Leqembi (lecanemab) for the treatment of mild cognitive disorders (memory and speech disorders). thought) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) »said the EMA in a press release.
The treatment is only recommended for patients who have not yet reached an advanced stage of the disease, the agency said. Other restrictions are imposed by the EMA, which had refused to place the drug on the market due to the risk of serious side effects, including potential bleeding in the brain. Only patients with a single or no copy of the ApoE4 gene, known to cause cerebrovascular damage (edema or hemorrhage), called amyloid-related imaging abnormalities (ARIA), will therefore be eligible for treatment. Likewise, it is not intended for people on anticoagulants who are at risk of having a stroke.
Authorized in 2023 in the United States
It is in this restricted population, evaluated during the re-examination of the clinical trials of the drug, that “the benefits in slowing the progression of symptoms of the disease outweigh its risks”indicates the EMA. She also specifies that the medication “will be available with a controlled access program to ensure that it is only used in the recommended patient population”. Thus, those affected will have to undergo magnetic resonance imaging to monitor that there are no ARIAs before the start of treatment and then before the fifth, seventh and fourteenth doses.
“This is good news for patients”explains, MondeNicolas Villain, neurologist at Pitié-Salpêtrière (AP-HP). He estimates between 5% and 15% in France the proportion of patients affected by Alzheimer’s disease who meet the criteria for access to this medication.
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– What are the potential side effects of lecanemab and how might they affect patient eligibility for treatment?
**Interview with Dr. Sarah Lambert, Neurologist and Alzheimer’s Researcher**
**Editor:** Dr. Lambert, thank you for joining us today. The recent approval of lecanemab, marketed as Leqembi, by the European Medicines Agency (EMA) marks a significant step in Alzheimer’s treatment. Can you explain how this drug works?
**Dr. Lambert:** Certainly! Lecanemab is a monoclonal antibody that targets beta-amyloid, a protein that forms plaques in the brains of Alzheimer’s patients. By attaching to these plaques, lecanemab helps to reduce their presence, which is believed to slow cognitive decline in patients in the early stages of the disease.
**Editor:** That sounds promising! The EMA specified that lecanemab is intended for patients with mild cognitive disorders or mild dementia due to Alzheimer’s. What does this guidelines mean for potential patients?
**Dr. Lambert:** The restriction to early-stage patients is crucial. It indicates that the treatment is intended to be most effective before the disease progresses significantly. This is when we can still see meaningful cognitive improvements, making early detection and diagnosis vital.
**Editor:** You mentioned the importance of early detection. Given that nearly a million people are affected by Alzheimer’s in France alone, what can you say about the current state of awareness and diagnosis?
**Dr. Lambert:** Awareness has definitely improved over the years, but there’s still a long way to go. Many individuals and families might overlook early symptoms due to the stigma around the disease or misconceptions about aging. It’s essential for healthcare providers to encourage discussions about cognitive health during routine check-ups, especially with patients who are at risk.
**Editor:** The approval of lecanemab comes after some controversies. In July, the EMA issued a negative opinion regarding its use. Can you shed light on why there might have been hesitance in approving the treatment initially?
**Dr. Lambert:** Yes, the EMA had concerns about the efficacy and safety of lecanemab. In clinical trials, while some patients showed cognitive improvement, others experienced serious side effects. These concerns prompted a need for further investigation into balancing its benefits against risks. The recent change in stance suggests that new evidence may have addressed those initial concerns.
**Editor:** what does the approval of Leqembi mean for the future of Alzheimer’s treatment and research?
**Dr. Lambert:** This approval is a landmark moment. It not only opens the door for new treatment options for early-stage Alzheimer’s patients but also encourages further research into other potential therapies. The hope is that as we learn more about the disease and its mechanisms, we can develop more advanced treatments that will benefit patients across all stages of Alzheimer’s.
**Editor:** Thank you, Dr. Lambert, for your insights. This progress in Alzheimer’s treatment could bring hope to many families affected by the disease.
**Dr. Lambert:** Thank you for having me. It’s crucial that we continue to promote research and support for Alzheimer’s awareness.