The European medicines regulator is reviewing its initial negative opinion issued last July and authorizing the marketing of lecanemab, a treatment intended for people with early-stage Alzheimer’s disease and aimed at slowing cognitive decline. The review concludes that the benefits outweigh the risks in a small patient population.
As a reminder, in July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the use of lecanemab – marketed under the name Lequambi by the Eisai and Biogen – in a larger population including all patients with early Alzheimer’s disease. After re-examining its initial opinion, the CHMP has finally recommended the marketing authorization of this molecule for the treatment of mild cognitive disorders (memory and thinking problems) or mild dementia due to dementia. Alzheimer’s (early Alzheimer’s disease) in patients who have only one or no copies of ApoE4, a certain form of the apolipoprotein E protein gene.
Patients with a single or no copy of ApoE4 are indeed less likely to have amyloid-related imaging abnormalities (ARIA) than people with two copies of ApoE4. ARIA is a recognized serious side effect of Leqembi that involves swelling and potential bleeding in the brain.
The Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) concluded that, in the limited population assessed in the review, the benefits of lecanemab in slowing the progression of disease symptoms outweigh its risks.
The EMA specifies, however, that the administration of the infusion treatment will be carried out under strict medical supervision by qualified personnel, with regular access to MRI-type imaging. The objective is to guarantee the safety of the treatment, by verifying the absence of complications linked to its administration. These recommendations are similar to those issued in other countries where lecanemab has already been approved, such as the United States, Japan or more recently the United Kingdom.
• « Leqembi recommended for treatment of early Alzheimer’s disease », 14 November 2024, European Medicines Agency.
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