Doctors and foundations are welcoming the approval of Lekembi, a drug that slows the progression of Alzheimer’s disease.
Alzheimer’s doctors, foundations and general practitioners applaud expert committee’s change of position European Medicines Agency (EMA, its English acronym), which on Thursday revised its position and finally recommended marketing in the European Union. ‘Lekembi’ (the active substance of which is lecanemab). It is the first drug to demonstrate clinical benefit against this disease, the leading cause of dementia in the world. Last July, the EMA rejected the same drug due to complications such as brain hemorrhages and swelling.
Patient organizations, researchers and Alzheimer’s disease professionals in Spain welcomed the decision. From Spanish Confederation of Alzheimer’s and other dementias (CEAFA)described the EMA’s correction as “very good news” that “avoids the discrimination” that European patients may have suffered compared to other countries where the drug is already available.
Spanish Society of Neurology (SEN) Yesterday welcomed the EMA’s recommendation, “similar to that already made by the UK Medicines and Healthcare Products Regulatory Agency, which, in addition to placing restrictions on the use of this drug, exclude patients with a higher risk of complications, such as patients with two copies of the ApoE4 gene , emphasizes that the drug will only be available through a controlled access program,” the doctor explained in a statement. Raquel Sanchez del ValleSEN Behavior and Dementia Group Coordinator. Lecanemab is planned to be administered intravenously twice a month.
Spanish Agency for Medicines and Health Products (AEMPS)) yesterday clarified that the pharmaceutical laboratory producing Lekembi should create a registry of studies of patients treated with the drug throughout the EU to determine the frequency and severity of possible adverse reactions caused by it.
Pascual Maragall Foundation And ACE Alzheimer’s Center Barcelona Yesterday they called the EMA’s recommendations “important progress” that “opens a window of hope for patients and families living with Alzheimer’s disease.” Doctor Merce Boadacreator of the ACE Alzheimer’s Center, told Efe that this would be “the enormous progress we have been waiting for since the last Alzheimer’s drug was approved in 2003.”
Neurologist Pablo Martinez-Lagescientific director of the CITA-Alzheimer Foundation, told SMC that the drug “changes disease progression in people diagnosed with Alzheimer’s disease while they are still living normal or near-normal lives” and is “only for people who are diagnosed very early,” he added.
“After 20 years of no major advances in the treatment of Alzheimer’s disease, it appears that a new path is beginning to be blazed. some hope. The use of monoclonal antibodies against amyloid peptide represents the first and small step towards obtaining effective treatments for this disease,” said, for his part, Jordi Perez-TourSenior Researcher, CSIC, Institute of Biomedicine of Valencia (CSIC-CIBERNED). This expert also remembers that regarding this treatment, which “has been shown to have some effectiveness as long as it is used persons in the early stages of the disease or diagnosed with mild cognitive impairmentIn addition, patients must meet the genetic requirement that “they do not carry any copy of the E4 allele in the Alzheimer’s gene.” APOE (apolipoprotein E)“. Therefore, he emphasizes, “We are not in danger of destructive treatment. However, this is a much-needed, long-awaited and long-awaited new product.”
Perez-Tur explains to SMC that “25 years ago, experimental models of Alzheimer’s disease began to be treated with antibodies directed against amyloid peptide, a major component of the damage seen in patients’ brains.. In these models, the results were impressive. The lesions disappeared over time, and treated animals performed better on memory tests. However, these results were not immediately translated to humans. It took intensive work in the laboratory to obtain formulations effective enough to gain regulatory approval in several countries around the world, including Europe, albeit with the conditions stated above.”
Why is this drug allowed now if the EMA rejected it in July? Jordi Perez-Tur explains that at that time “it was used in all patients in the initial stages of the disease, and it was clear that this treatment did more harm than good for all patients, since a significant increase in the occurrence of cerebral edema or hemorrhage was observed in the antibody group. That is, the benefit observed in terms of asthma progression was lower than the risk of severe symptoms associated with the treatment rather than the disease.”
However, Perez-Tour continues, “in a subsequent analysis, the pharmaceutical companies promoting this treatment (Eisai and Biogen) saw how much more effective it was in a subgroup of patients (those with one copy of the E4 allele in the gene or none). . belonging APOE). This new way of looking at data has now allowed approval of the treatment subject to the above conditions: patients in the early stages or diagnosed with mild cognitive impairment who carry no more than one copy of the E4 allele. However, the effectiveness of treatment, contrary to what one might think, does not consist of stopping or reversing the disease. The effect achieved was to slow down its progress for at least the 18 months that clinical trials continued. were being studied for approval of lekembi for the treatment of Alzheimer’s disease,” he concludes.
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