Leqembi, a new treatment against Alzheimer’s diseasereceived, on November 14, a recommendation from the European Medicines Agency (EMA) for marketing. This avis “is an intermediate step on Leqembi’s path towards patient access to medicine”. The European Commission must now validate this recommendation. “It still has to go before the European Commission for a favorable European opinion, then there will be an examination in each agency in each country that wants to put it on the market with then a discussion of the price. We should reasonably have it in a few months “, indicated to Franceinfo Philippe Amouyel, professor of public health at Lille University Hospital and director of the Plan Alzheimer Foundation.
Leqembi: why did the European Medicines Agency come out in favor of this treatment?
This announcement follows a re-evaluation after a initial refusal formulated last July. In question, at that moment, a risk that was too high “serious side effects” related to taking this treatment. At the time of its refusal last July, the France Alzheimer association regretted this decision, recalling that “the lack of new effective treatments limits the options available to slow the progression of the disease and improve the quality of life of people with Alzheimer’s”, and to urge laboratories to continue their research work.
Following the refusal of the European Medicines Agency last July, a review of this treatment was carried out. After examining the effects of Leqembi on a smaller panel of 1,521 patients, researchers noted the effectiveness of this treatment as well as a lower risk of side effects. Also, the authorities concluded that “the benefits of Leqembi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.”
— EU Medicines Agency (@EMA_News) November 14, 2024
New treatment against Alzheimer’s disease: who will Leqembi be intended for?
The aim of this treatment, to be administered by drip into the veins once every two weeks, is to delay cognitive decline. It targets beta-amyloid, a substance that “forms plaques in the brains of patients with Alzheimer’s disease”. Also, in “By binding to beta-amyloid, Leqembi reduces amyloid plaques in the brain”, details the European Medicines Agency (EMA).
Leqembi is intended for people suffering from mild cognitive impairmentsuch as memory problems or an early form of Alzheimer’s disease. The health authorities specify that will be affected “patients who have only one or no copies of ApoE4, a certain form of the apolipoprotein E gene.” Indeed, as authorities explain, these patients have less risk of a side effect of the treatment called amyloid-related imaging abnormalities (ARIA), which can cause swelling and bleeding in the brain.
Leqembi: how will patients be monitored to reduce the risk of side effects?
However, certain measures must be taken beforehand to reduce the risk of serious side effects. Indeed, at the time of its marketing, this treatment “will be available through a controlled access program to ensure that the medicine is only used in the recommended patient population.” Patients will have to undergo a series of examinations, including one magnetic resonance imaging (MRI) at the start of treatment and then at different stages of treatment. The aim is to monitor the risk of side effects. Additionally, if symptoms such as headache, confusion, visual disturbances, dizziness, nausea and difficulty walking occur, additional MRI scans may be performed.
The Leqembi is already available in the United Statesin the United Kingdom, Japan and China.
Sources :
- Leqembi recommended for treatment of early Alzheimer’s disease – European Medicines Agency (EMA) – 14/11/2024
- Leqembi: marketing refused in Europe – France Alzheimer – 07/26/2024
- Alzheimer’s: the decision of the European Medicines Agency to approve an expected treatment “brings hope”, for Professor Philippe Amouyel – Franceinfo (14/11/24).
