The United States has authorized a long-awaited new treatment for Alzheimer's

The United States has authorized a long-awaited new treatment for Alzheimer’s

(Washington) Les autorités sanitaires américaines ont autorisé vendredi un nouveau médicamente contre Alzheimer visant à réduire le déclin cognitif des pacientes suuffrant de cette maladie neurodégénérative, un treitement très attendu après le lancement raté d’un précédent médicament au mécanisme similaire y il ya un medium.

The new treatment, which will be marketed under the name Leqembi, is now recommended by the US Food and Drug Administration (FDA) for patients who have not yet reached an advanced stage of the disease.

Administered intravenously once every two weeks, it is developed by the Japanese pharmaceutical company Eisai, in association with the American Biogen.

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

Leqembi, whose active ingredient is called lecanemab, attacks deposits of a protein called beta-amyloid. While the exact cause of Alzheimer’s disease remains poorly understood, the brains of patients show amyloid plaques, which form around their neurons and eventually destroy them.

This is what causes the memory loss characteristic of the disease. In the later stages, patients are no longer able to perform daily tasks or hold conversations.

The FDA approval 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 and full data for which the FDA expects to receive “soon.”

Conducted in nearly 1,800 people followed for 18 months, these trials revealed a 27% reduction in cognitive decline in patients treated with lecanemab. A novelty for a drug of this type.

But the study also revealed serious adverse effects: some of the treated patients suffered brain haemorrhages. At least one person who received the treatment has died.

“Given these concerns, whether lecanemab will truly be a game changer, as some say, remains to be proven,” the experts wrote in the scientific journal. the lancet beginning of December.

The FDA included a warning about the risk of bleeding in the drug information.

$26,500 per year

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

This is the second Alzheimer’s treatment recently approved by the FDA, following Aduhelm in June 2021 (which uses a molecule called aducanumab). Also produced by the companies Biogen and Esai, and also directed at amyloid plaques, it was the first drug launched on the market for this disease in almost two decades.

But its launch had not been as successful as expected: its authorization had sparked controversy, with some experts criticizing the lack of evidence on its effectiveness. Later, its use was restricted to people with moderate cases of the disease.

A recent US parliamentary report also blamed its exorbitant price ($56,000 USD per year). The federal health insurance system Medicare, intended for the elderly, had announced that it would only reimburse it if it was taken in the context of clinical trials.

Leqembi will launch at a price of $26,500 a year, with the goal of “promoting patient access, reducing the overall financial burden, and supporting the sustainability of the healthcare system,” Eisai announced in a press release on Friday.

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

“People with this deadly disease have no time to wait for a miracle cure,” Joanne Pike, president of the Alzheimer’s Association, said in a statement, calling for Medicare to reimburse Leqembi.

It has been approved under an accelerated program of the FDA, which allows for faster authorization of treatments against serious pathologies and those that can no longer be treated effectively.

For decades, researchers have failed to make a real breakthrough in the fight against Alzheimer’s disease, which is why the authorization of this new class of treatment has raised such hopes among some. But there is still no remedy that allows a cure to this day.

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