The European Medicines Agency (EMA) has approved in Europe a promising drug against Alzheimer’s that it had rejected in July. This is lecanemab, a monoclonal antibody that, unlike the symptomatic treatments administered until now, acts on the anti-amyloid protein, which accumulates in patients with the disease and causes cognitive deterioration. It is the first drug approved against this dementia in Europe in the last 20 years.
In the summer, the agency alleged that The benefits of the Biogen and Eisai drug did not outweigh the side effects observedin reference to some cases of hemorrhage that caused the death of two patients during the trials. Furthermore, a ‘Neurology’ study in 2023 had described a “shrinkage” of the brain in some study participants.
However, lecanemab, marketed under the name Leqembi, It has been used in the United States for a year now. Its regulatory agency, the FDA, approved it urgently in January 2023, after being shown to reduce patients’ cognitive decline by 27%.
Since then, both experts and those affected by the disease have been demanding the approval of the drug in Europe, since it has also been shown that, if these treatments are provided in earlier stages of the disease, progress could be slowed down by up to 60%.
Asked by this newspaper, the neurologist, expert in dementia and scientific director of the Neurological Diseases Research Center Foundation (CIEN), Pascual Sánchez Juan, recognizes that the risk-benefit balance can be “improved”, but insists on its ability to stop the symptoms of the disease, so he trusted the positive opinion of the EMA.
Thus, he clarifies that it is true that “the fundamental side effect” of these anti-beta-amyloid drugs are those known as “arias”, inflammations that occur in the brain that in some cases can lead to bleeding. However, the solution to avoid this damage, in his opinion, is to “make a better selection of patients through precision medicine”, ruling out those with risk factors for bleeding.
With regards to a possible brain shrinkage, The expert clarifies that “it’s not that much of a problem”. “What has been seen, probably, is a phenomenon of pseudoatrophy. Atrophy is when neurons die. But it does not seem to be that, but that the treatment removes an amyloid protein and that entails changes, reduces inflammation, reduces the deposit of that protein and that causes volume to be lost,” he explains. Thus, he continues, “it does not seem to be a side effect because the patients do not get worse, but on the contrary, they stabilize.”
Beyond lecanemab, right now there are several drugs that are in the development pipeline, “and that balance risk-benefit is going to be better“says Sánchez-Juan. “These first drugs are the pioneers and, as has happened in cancer, the improvement is modest, but they represent a first step on which to base everything that comes,” he predicted, to remember that in In the last 20 years there has been no positive progress in Alzheimer’s because all the drugs that were approved in the clinical phase “failed.”
#Europe #rectifies #green #light #drug #Alzheimers
