EMA recommends approval of lecanemab for the treatment of early-stage Alzheimer's disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization to lecanemab (trade name Leqembi) in Europe, a drug that slows the progression of early-stage Alzheimer's disease.

Following a review by the EMA after an initial negative opinion in July this year, the Committee has reviewed the available evidence and recommended approval, considering that the benefits of lecanemab for a restricted population outweigh the risks. The use of lecanemab is indicated for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer's disease, although it can only be administered to patients with one or no copies of the ApoE4 allele of the ApoE gene, a risk factor associated with the disease.

The CHMP recommendation marks a milestone in the treatment of Alzheimer's disease, as lecanemab has demonstrated for the first time the ability to slow the progression of the disease by 27% by reducing beta-amyloid protein plaques in the brain, a specific characteristic of Alzheimer's disease. This breakthrough represents the beginning of a new approach in research and innovation to treat this pathology.
In the words of Dr. Arcadi Navarro, General Director of the Pasqual Maragall Foundation: “This is magnificent news, as the approval of lecanemab will not only mean that patients in the early stages of the disease can benefit from this treatment, but also opens the door to other innovative drugs and a profound change in Alzheimer's research, diagnosis and treatment that will make it possible to put an end to this disease”.

The EMA has specified that lecanemab will be available through a controlled access program to ensure that the medicine is used exclusively in the recommended patient population. In addition, the pharmaceutical companies, Eisai and Biogen, will be required to conduct a European registry of patients treated with the drug to assess the possible incidence of side effects and to collect information on patient progression.

Lecanemab in European healthcare systems

Following the CHMP opinion, it is expected that the EMA will grant authorization for its marketing and that negotiations will begin for its inclusion in the different healthcare systems in each of the EU countries. Availability will not be immediate and depends on the negotiation processes in each country, and rapid inclusion would be a great step forward in facilitating access to treatment for people with Alzheimer's disease who are currently in the early stages of the disease's development. 

In the words of Dr. Navarro “It is crucial to accelerate the process of including lecanemab in Spain. Alzheimer's disease represents an unmet medical need that affects 900,000 families in our country. Having this treatment available as soon as possible could make a big difference for many patients in the early stages of the disease, delaying the progression of cognitive impairment and improving the quality of life of both those affected and their caregivers. In addition, rapid inclusion would open the way for other innovative drugs, driving new therapeutic options and significant progress in the fight against this devastating disease.”

With this decision, Europe will join the list of countries that have already approved lecanemab for the treatment of Alzheimer's. Lecanemab was approved by the US Food and Drug Administration (FDA) in July 2023, and was the first to be approved through the traditional route of the American regulatory agency that intervenes in the progression of the disease. In addition, it has also been approved by the regulatory authorities in China, Hong Kong, Israel, Japan and South Korea, among other countries.