The Committee for Medicinal Products for Human Use (CHMP) of the EMA (European Medicines Agency) has recommended granting marketing authorisation in Europe for lecanemab (trade name Leqembi), a drug that slows the progression of Alzheimer's disease in its early stages.
Following the review carried out by the EMA after a first negative opinion in July of this year, the Committee has reviewed the available evidence and has recommended its 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 in 27% by reducing the beta-amyloid protein plaques in the brain, a characteristic of Alzheimer's disease. This advance marks 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 wonderful 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 it also opens the door to other innovative drugs and a profound change in the research, diagnosis and treatment of Alzheimer's that will allow us to put an end to this disease.”.
The EMA has specified that lecanemab will be made available through a controlled access programme to ensure that the drug is used exclusively in the recommended patient population. In addition, the pharmaceutical companies, Eisai and Biogen, will have to carry out a European registry of patients treated with the drug to assess the possible incidence of side effects and collect information on the progression of patients.
Lecanemab in European health systems
Following the CHMP opinion, the EMA is expected to grant marketing authorisation and to begin negotiations for its inclusion in the different health 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 represent a major step forward in facilitating access to treatment for people with Alzheimer's who are currently in the early stages of the development of the disease. In the words of Dr. Navarro “It is crucial to speed up the process of inclusion of lecanemab in Spain. Alzheimer's 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 decline and improving the quality of life of both those affected and their caregivers. In addition, rapid inclusion would pave the way for other innovative drugs, promoting 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. In July 2023, the drug was approved by the FDA (US Food and Drug Administration), and was the first to be approved through the traditional route of the US regulatory agency that intervenes in the progression of the disease. In addition, it has also been approved by regulatory authorities in China, Hong Kong, Israel, Japan and South Korea, among other countries.
