the European Medicines Agency approves a treatment reserved for certain patients

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.

“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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