The European Medicines Agency (EMA) has finally approved a treatment aimed at reducing the cognitive deterioration related to early-stage Alzheimer’s disease. In July, the EMA issued a negative opinion on the use of lecanemab, marketed under the name Leqembi. Almost a million people are affected by the disease in France and 35.6 million worldwide. Lecanemab is a monoclonal antibody (a type of protein) that binds to a substance called beta-amyloid, which causes plaques to form in the brains of patients with Alzheimer’s disease. In this way it is intended to reduce these plaques.
“The EMA Committee for Medicinal Products for Human Use recommended, on Thursday, November 14, granting marketing authorization to Leqembi (lecanemab) for the treatment of mild cognitive disorders (memory and thinking disorders) or mild dementia due to Alzheimer’s disease (early). Alzheimer’s disease) »the EMA stated 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 market the drug due to the risk of serious side effects, including possible brain hemorrhage. Therefore, only patients with a single or no copy of the ApoE4 gene, which is known to cause cerebrovascular damage (edema or hemorrhage), called amyloid-related imaging abnormalities (ARIA), will be eligible for treatment. Also, it is not intended for people who take blood thinners and are at risk of stroke.
Authorized in 2023 in the United States.
It is in this restricted population, evaluated during the reexamination of the drug’s clinical trials, where “the benefits of slowing the progression of the disease’s symptoms outweigh its risks”indicates the EMA. It also specifies that the medication “will be available with a controlled access program to ensure it is only used in the recommended patient population”. Thus, those affected will have to undergo an MRI to check that there is no ARIA before the start of treatment and then before the fifth, seventh and fourteenth dose.
“This is good news for patients”explains, WorldNicolas Villain, neurologist from Pitié-Salpêtrière (AP-HP). The proportion of patients affected by Alzheimer’s disease who meet the criteria to access this medication is estimated to be between 5% and 15% in France.
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