BarcelonaIn a decision that has surprised experts from all over, the European Medicines Agency (EMA, in English) this Friday advised against the use of the first medicine that manages to slow down the progression of Alzheimer’s symptoms, since it considers that the its effect on cognitive impairment does not compensate for the risk of side effects associated with the drug. Leqembi, the commercial name of the drug lecanemab, had generated some concern for the appearance of abnormalities such as “inflammation and possible bleeding in the brain” in some of the patients taking it. At the same time, however, many experts defended its usefulness despite these adverse effects.
The decision of the regulatory agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the European Commission should not approve the use of this medicine, which has been marketed in the United States and reduces the cognitive damage of people suffering from the disease by up to 27%. The body has issued a statement in which it announces its decision in this way: “After 18 months of treatment, we have concluded that the effects of lecanemab to counteract cognitive impairment do not compensate for the risk of serious side effects”, they have al legacy Although these are side effects that only appear occasionally and most have no symptoms or experience a mild headache, EMA advisors point out that “there are patients who suffered brain haemorrhages that required hospitalisation”.
Neurodegenerative diseases are irreversible and have no cure. From the moment of diagnosis, they progress without stopping and are characterized by neuronal death and a progressive disability of the affected person. They are diseases as complex as the functioning of the brain and the causes of the vast majority, such as Alzheimer’s, are still unknown. The last three decades have been decisive in the fight against this pathology, although there have been few significant advances that improve the quality of life of patients. Lecanemab had been presented to the world as one of the most promising tools to improve the quality of life of these people who receive a diagnosis in the early stages of Alzheimer’s, when there is therefore room to change the course of the disease
The Food and Drug Administration of the United States, the FDA (Food and Drug Administration), had 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 will be a wide range of therapies to slow the progression of Alzheimer’s. In any case, the American regulator recommends not prescribing Leqembi to patients using anticoagulant medication, as it increases the risk of cerebral hemorrhages and they emphasize that “it should only be used in people with mild cognitive impairment and 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 were waiting for the drug’s approval. They point out that this measure by the EMA will cause Europe to fall behind in the search for drugs to combat this neurodegenerative disease: “Patients in Europe are discriminated against, because they will not have the same opportunities as people from other countries”, he explained the neurologist and medical director of ACE Alzheimer Center Barcelona, Mercè Boada, who has dedicated her professional career to Alzheimer’s research. “I’m sure we will now see wealthy people in the early stages of the disease flying to the United States for treatment,” predicted the professor of neuroscience and head of the group at the UK’s Dementia Research Institute. ‘University School of London (UCL), John Hardy, speaking to SMC.
Boada has claimed that the quality of patients and family members, as well as research capacity at the state level, will be affected and will “impoverish” the healthcare system, since it will not be possible to collect “real world” data to adjust and improve the frequency and doses of new products that may appear. “We will pass through the desert again. We are in the middle of a drought, once again,” he lamented.
Also for the neurologist at the Cognitive Deterioration Unit of the Marqués de Valdecilla-IDIVAL University Hospital and professor at the Department of Medicine and Psychiatry at the University of Cantabria, the EMA’s decision is “very negative”. The expert laments to SMC that the resolution basically alludes to its debatable clinical relevance and its side effects. In this case, he questions that the use of the drug has not been restricted to some patients and that he has chosen to refuse it “without consideration”. “(These treatments) are not the panacea, but there are groups of patients who can benefit with a low (and acceptable) rate of side effects. And we cannot deny them this opportunity, it is unethical,” he concludes.
Instead, the president of the British Neuroscience Association, Tara Spiers-Jones, wanted to convey a message of hope: “The decision of the EMA will be a disappointment for many, but it should be noted that lecanemab has shown good results and has shown that research works.” In this way, the expert pointed out to SMC that it is necessary to “redouble research efforts to discover new and safer treatments”.
Source: www.ara.cat
