United States authorizes long-awaited new treatment for Alzheimer’s – Science et Avenir

U.S. health authorities on Friday approved a new Alzheimer’s drug aimed at reducing cognitive decline in patients suffering from the neurodegenerative disease, a welcome treatment after the failed launch of a previous drug with a similar mechanism a year and a half ago.

The new drug, which will be sold under the name Leqembi, is currently recommended by the American Medicines Agency (FDA) for patients whose disease has not yet reached an advanced stage.

Given intravenously once every two weeks, it was developed by the Japanese pharmaceutical company Eisai in partnership with the American Biogen.

This represents “an important step forward in our fight to effectively treat Alzheimer’s disease,” which affects about 6.5 million Americans, the FDA said in a statement.

The drug Lekambi, whose active ingredient is called lecanemab, acts on deposits of a protein called beta-amyloid. Although the exact cause of Alzheimer’s remains poorly understood, amyloid plaques are found in patients’ brains that form around their neurons and eventually destroy them.

This is what causes the memory loss characteristic of the disease. In later stages, patients can no longer perform daily tasks or carry on conversations.

The FDA approval is based on the results of clinical trials, which showed that the drug helped reduce amyloid plaques.

The agency also cites results from larger clinical trials recently published in a scientific journal, and the FDA expects full data “soon.”

These trials, conducted on nearly 1800 people over 18 months, found a 27% reduction in cognitive decline in patients treated with lecanemab. For the first time for a drug of this type.

But the study also revealed serious side effects: some patients who received the treatment had brain hemorrhages. At least one person who received treatment has died.

“Given these concerns, it remains unproven whether lekanemab is truly a game changer,” the experts wrote in the scientific journal The Lancet in early December.

The FDA has included a bleeding risk warning in the product information.

– $26,500 per year –

According to an Eisai press release, approximately 100,000 people could receive this treatment in the United States within three years, given the eligibility criteria (mild cognitive impairment and evidence of amyloid plaques).

This is the second Alzheimer’s treatment recently approved by the FDA, after Aduhelm in June 2021 (which uses a molecule called aducanumab). It was also produced by Biogen and Esai and also acted on amyloid plaques. It was the first drug for this disease to be marketed in nearly two decades.

But its launch was not the expected success: its approval was controversial, with some experts criticizing the lack of evidence for its effectiveness. Later, its use was limited to people with moderate cases of the disease.

A recent report from the US Parliament also blamed its exorbitant price ($56,000 per year). Medicare, a federal health insurance system designed for the elderly, has announced that it will only reimburse it if it is accepted in the context of a clinical trial.

Leqembi will be launched at a price of $26,500 per year with the goal of “facilitating patient access, reducing the overall financial burden, and supporting healthcare system resilience,” Eisai announced Friday in a press release.

Medicare coverage of this new treatment has not yet been decided.

“People living with this deadly disease don’t have time to wait for a miracle cure,” Alzheimer’s Association President Joan Pike said in a statement, urging Medicare to agree to reimburse Lekambi.

It has been approved under the FDA’s Accelerated Program, allowing faster resolution of serious conditions that are no longer amenable to effective treatment.

For decades, researchers have not been able to achieve a real breakthrough in the fight against Alzheimer’s, which is why the approval of this new class of treatment has raised so many hopes for some. But there is still no cure.

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