The United States Food and Drug Administration (FDA for its acronym in English) authorized this Friday a new treatment for Alzheimer’s intended to reduce cognitive decline in patients suffering from this neurodegenerative disease.
The new treatmentwhich will be marketed by the pharmaceutical company Eisai under the name of leqembi, it is recommended by the FDA for patients who have not yet reached an advanced stage of the disease.
The active principle of the drug authorized against Alzheimer’s by the FDA is named lecanemab, and attacks deposits of a protein called beta-amyloid.
The FDA clearance is based on the results of clinical trials that showed that the drug helped reduce amyloid plaques.
And it is that, although the cause of the Alzheimer disease it remains little known; patients present with amyloid plaques in the brain, which form around neurons and eventually destroy them. This is what causes the memory loss characteristic of the disease.
Studies conducted in nearly 1,800 people who were followed for 18 months revealed a 27% reduction in cognitive decline in patients treated with lecanemab.
However, clinical trials also showed serious adverse effects: some of the treated patients suffered brain hemorrhages. In addition, at least one person who received the treatment died, so the FDA included a warning about the bleeding risk in the drug information.
Regarding the approval, the FDA said in a statement that “this drug represents “an important step in our battle to effectively treat Alzheimer disease“.
This is the second FDA-approved Alzheimer’s treatmentafter the aduhelm in June 2021 (which uses a molecule called aducanumab).
But the release of aduhelm did not have the expected success. His authorization sparked controversy, as some experts criticized the lack of evidence on its effectiveness. Later, its use was restricted to people with moderate cases of the disease.