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The European Medicines Agency has finally accepted the marketing of two new treatments whose effectiveness is marginal and the risks are very real. What will the High Authority of Health do?
Continuation and not end of the Leqembi affair. Because the file for this anti-Alzheimer drug has become that of a business, far in any case from a simple and new therapeutic advance. It is terribly revealing of the balance of power and the ambiguous games around drugs and their possible arrival on the market, especially when the market is potentially… enormous.
Last episode therefore, Thursday November 14: the committee for the evaluation of medicinal products for human use of the European Medicines Agency (EMA) recommended granting “a marketing authorization in the territory of the European Union for Leqembi, the marketing name of Lecanemab”. Intended for people affected by Alzheimer’s disease at an early stage of the pathology, the treatment aims to slow down cognitive decline. This decision is a little surprising because, in July 2024, the Eisai laboratory, responsible for the development of Lecanemab, had received a formal refusal from the EMA, with solid reasons: the increased risk of serious side effects, including bleeding in the brain, but also limited clinical interest. So what happened to cause the same authority to change its mind in a few months?
Questionable evaluation scales
The EMA, in its decision, now says
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