US health authorities on Friday (January 6th) authorized a new Alzheimer’s drug aimed at reducing cognitive decline in patients suffering from this neurodegenerative disease, a much-anticipated treatment after the failed launch of a previous drug with a similar mechanism a year ago and half.
The new treatment, which will be marketed by the pharmaceutical company Eisai under the name Leqembi, is now recommended by the United States Medicines Agency (FDA) for patients who have not yet reached an advanced stage of the disease.
This treatment represents “an important step forward in our battle to effectively treat Alzheimer’s disease”which affects some 6.5 million Americans, the FDA said in a statement.
Reduce amyloid plaques
Leqembi, whose active ingredient is called lecanemab, targets deposits of a protein called beta-amyloid. Although the cause of Alzheimer’s disease remains poorly understood, patients have amyloid plaques in their brains, which form around their neurons and eventually destroy them.
This is what causes the memory loss characteristic of the disease. The FDA clearance is based on clinical trial results that showed the drug helped reduce amyloid plaques. The agency also mentions the results of larger clinical trials, recently published in a scientific journal.
Conducted on nearly 1,800 people followed for 18 months, they revealed a 27% reduction in cognitive decline in patients treated with lecanemab. But the study also revealed serious adverse effects: some of the patients treated suffered from cerebral hemorrhages. Additionally, at least one person who received the treatment has died.
Prix exorbitant
The FDA included a warning about the risk of bleeding in the drug information. This is the second Alzheimer’s treatment recently approved by the FDA, after Aduhelm in June 2021 (using a molecule called aducanumab).
But its launch had not been the expected success: its authorization had sparked controversy, with some experts criticizing the lack of evidence on its effectiveness. Its use was later restricted to people with moderate cases of the disease.
A recent US parliamentary report also blamed its exorbitant cost (more than €52,000 per year), and the federal health insurance system Medicare, intended for the elderly, had announced that it would only reimburse it if it was carried out within the framework of ‘clinical tests.