2024-07-26 18:46:38
BarcelonaIn a decision that has surprised experts everywhere, the European Medicines Agency (EMA, in English) advises against the use of the first drug that manages to slow the progression of Alzheimer’s symptoms this Friday, since it is noted that its effect on cognitive impairment does. does not compensate for the risk of side effects associated with the drug. Leqembi, the trade name of the drug lecanemab, has generated concern for the appearance of abnormalities such as “inflammation and possible bleeding in the brain” in some patients who took it. At the same time, however, many experts defend its usefulness despite these negative effects.
The decision of the Parliamentary Committee for the Control of Medicinal Products for Human Use (CHMP) has concluded that the European Commission should not approve the use of this drug, which has been marketed in the United States and reduces the cognitive damage of people with the disease that. by up to 27%. The body issued a statement in which it announced its decision in this way: “After 18 months of treatment, it has been determined that the effects of lecanemab to combat cognitive impairment do not compensate for the risk of serious side effects”, they said al . twenty Although these are side effects that appear occasionally and most do not have symptoms or experience a mild headache, EMA experts point out that “there are patients who suffer from cerebral hemorrhage that requires hospitalization”.
Neurodegenerative diseases are irreversible and incurable. From the time of diagnosis, they progress without delay and are characterized by neuronal death and progressive disability of the affected person. They are difficult diseases as the functioning of the brain and the causes of many, such as Alzheimer’s, are unknown. The past three decades have been decisive in the fight against this pathology, although there have been some significant improvements that improve the quality of life of patients. Lecanemab has been shown to the world as one of the most promising tools to improve the quality of life of these people who are diagnosed in the early stages of Alzheimer’s, when there is a chance to change the course of the disease.
The Food and Drug Administration of the United States, FDA (Food and Drug Administration), has already approved the marketing of lecanemab and another drug, called donanemab (authorized this July), a year ago, and experts predict that in the coming years. There are many therapies available to slow the progression of Alzheimer’s. In any case, the American regulator recommends not prescribing Leqembi to patients who use anticoagulant drugs, as it increases the risk of cerebral hemorrhage and they insist that “it should only be used in people who have low cognitive impairment and are in the early stages of the disease” .
“In the middle of a drought, once again”
The decision has been a setback for some researchers who are waiting for the drug’s approval. They point out that this measure by the EMA will make Europe fall behind in the search for drugs to fight this neurodegenerative disease: “Patients in Europe are excluded, because they will not have the same benefits as people from other countries -another language”, explains the neurologist and medical director of the ACE Alzheimer Center Barcelona, “I am sure that we will see rich people in the early stages of the disease flying to the United States for treatment,” Professor of Neuroscience and head of the group at the UK’s Dementia Research Institute previously said. UCL), John Hardy, addressed the SMC.
Boada has said that the quality of patients and family members, and research capacity at the state level will be affected and will “impoverish” the health system, because it will not be possible to obtain “real world” data to adjust and improve frequencies and Needles of new products that may appear. “We will go through the desert again. We are in the middle of a drought, once again,” he lamented.
Even for a neurologist at the Department of Cognitive Impairment of the University Hospital Marqués de Valdecilla-IDIVAL and professor at the Department of Medicine and Psychiatry at the University of Cantabria, the decision of the EMA is “very negative”. The expert lamented to the SMC that the decision basically refers to the controversial clinical relevance and its side effects. In this case, he asked that the use of the drug is not restricted to some patients and he has chosen to write “without thinking”. “[Aquests tractaments] They are not a panacea, but there are groups of patients who can benefit with a small (and acceptable) degree of side effects. And we cannot reject them in this world, it is unfair,” he concluded.
Instead, the president of the British Neuroscience Association, Tara Spiers-Jones, wants to convey a message of hope: “The decision of the EMA will be sad for many, but it should be noted that lecanemab has shown good results and has been shown. the study worked.” In this way, the expert pointed out to the SMC that it is necessary to “double research efforts to discover new and safe treatments”.
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