Alzheimer’s: what is Leqembi, this new drug finally authorized by the drug agency?

A victory for people suffering from Alzheimer’s disease. After speaking out last July against the marketing of Leqembi, a new treatment aimed at reducing patients’ memory problems, the European Medicines Agency (EMA) revised its position on Thursday November 14 . Its use is now approved and could help patients who have not yet reached an advanced stage of the disease. Explanations.

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Slow down the disease

The Leqembi is a new step in the fight against Alzheimer’s disease. But it does not cure it. Because despite decades of research, scientists have not yet managed to achieve a real breakthrough. The exact cause of this degenerative disease, which affects tens of millions of people around the world, is poorly understood. One certainty, however: the presence in the body of the gene ApoE4, is known to be one of the major risk factors for developing Alzheimer’s disease.

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Observation of the brains of patients suffering from Alzheimer’s shows the presence of amyloid plaques, which form around their neurons, causing their eventual destruction. It is this action that causes the memory loss characteristic of the condition. Until the final stages of the disease, when patients are no longer able to carry out daily tasks or have conversations.

Leqembi treatment, administered intravenously once every two weeks, helps target and reduce these amyloid plaques.

In terms of effectiveness, and after 18 months of treatment, patients treated with Leqembi showed a smaller increase in the CDR-SB score – a scale used to assess the severity of dementia – than those treated with placebo. Which indicates slower cognitive decline.

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It is therefore these positive results which finally allowed the marketing authorization of the treatment: “After having re-examined its initial opinion, the Committee for Medicinal Products for Human Use (CHMP) recommends granting a marketing authorization to Leqembi (lecanemab)”, therefore indicated the EMA, estimating that “the benefits outweigh the risks in a limited population of patients”.

Authorized for certain patients

Although it constitutes a definite step forward, Leqembi cannot be administered to all patients. Due potentially serious complications that it can cause in some of them – swelling and potential bleeding in the brain – patients with a particular genetic profile: a double copy of the gene ApoE4, are excluded from the list of patients who can benefit from the treatment.

Furthermore, a second criterion restricts the eligible population: the disease must not have yet developed (we then speak of an early stage). Thus, the drug will only be available “for the treatment of mild cognitive impairment (memory and thinking disorders) or mild dementia due to Alzheimer’s disease,” explained the EMA.