Europe turns things around and greenlights new Alzheimer’s drug

The European Medicines Agency (EMA) has approved a promising Alzheimer’s drug in Europe, which it abandoned in July.. It is lecanemab, a monoclonal antibody that, unlike the symptomatic treatments used so far, targets the anti-amyloid protein that accumulates in patients with the disease and causes cognitive decline. This is the first drug approved against this dementia in Europe in 20 years.

Over the summer, the agency claimed that The benefits of Biogen and Eisai did not outweigh the observed side effects.regarding some cases of bleeding that resulted in the death of two patients during the trial. Moreover, a 2023 Neuroscience study described brain “shrinkage” in some study participants.

However, lecanemab, sold under the name Lakembi,

It has been in use in the US for a year now. Its regulatory agency, the FDA, gave it emergency approval in January 2023 after it was shown to reduce cognitive decline in patients by 27%.

Since then, both experts and people affected by this disease have been demanding approval of the drug in Europe, since it has also been proven that if such treatment is carried out in the earlier stages of the disease, progress may slow down by up to 60%.

In response to a question from this newspaper, neurologist, dementia expert and scientific director of the Foundation for Research Centers for Neurological Diseases (CIEN) Pascual Sánchez Juan admits that the balance of risks and benefits can be “improved”, but insists on its ability to stop the symptoms of the disease, so he trusted the positive EMA conclusion.

So he explains that it is true that the “fundamental side effect” of these anti-beta amyloid drugs is what is called “aria”, inflammation that occurs in the brain and in some cases can lead to bleeding. However, he said the solution to avoiding this harm is to “better select patients using precision medicine” by excluding those with risk factors for bleeding.

Regarding possible brain shrinkage The expert clarifies that “it’s not that big of a problem”. “What was observed is probably a phenomenon of pseudoatrophy. Atrophy is when neurons die. But that’s not the point, the point is that the treatment removes the amyloid protein, and this entails changes, reduces inflammation, reduces the deposition of this protein. protein, and this leads to loss of volume,” he explains. This way, he continues, “it doesn’t seem like a side effect because patients don’t get worse, but rather they stabilize.”

In addition to lecanemab, several other drugs are currently in development, “and this balance the risk-benefit ratio will be better“, says Sanchez-Juan. “These first drugs are pioneers, and as with cancer, the improvement is modest, but they represent the first step on which everything that happens will be based,” he predicted, remembering that in the last 20 years there has been no positive progress in the treatment of Alzheimer’s disease because all drugs approved in the clinical phase have “failed.”