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FDA Approves New Alzheimer’s Drug For Progressive Disease

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New Alzheimer’s treatment approved in US slows disease progression in non-advanced people.

A new treatment for Alzheimer’s promises to slow patients’ cognitive decline. The drug has been approved by the US Food and Drug Administration, but more testing is needed. And there is no shortage of critical voices.

The Underlying Mechanisms of Alzheimer’s Are Affected

The Food and Drug Administration (Fda), the American body employed by the Department of Health that deals with the regulation of food and pharmaceutical products, has authorized the use of the new drug Leqembi for the treatment of Alzheimer’s disease.

The new drug was developed by the Japanese company Eisai and the Americans by Biogen.

Unlike previous generation treatments, Leqembi’s goal is not to relieve the symptoms of Alzheimer’s, but to target the mechanisms that underlie the disease’s progression, explained Billy Dunn, director of the neuroscience department at the Center for Drug Evaluation and Research of the FDA.

After twenty years of failure, research against Alzheimer’s seems to have accelerated in recent times: last year the first drug, Aducanumab, was approved, aimed at countering the decline of this disease whose cases seem to increase. Today comes the new drug Leqembi.

The Limits of The New Drug Against Alzheimer’s

But there are limitations: the drug is effective only in the treatment of those patients who have not yet reached an advanced stage of the disease.

Another limit is represented by the cost of the therapy: according to what is reported by the American media, each year of treatment will cost about 26 thousand dollars.

And that’s not all: the FDA has given the drug an accelerated green light, so further studies will be needed to more precisely verify the effectiveness of the therapy and any side effects.

There is no shortage of critical voices. Matthew Schrag, a neurology researcher at Vanderbilt University cuts it short: “Most patients won’t notice the difference. We are talking about a rather small effect and probably below the threshold of what we would define as clinically significant”.

Schrag comments on the results of tests carried out by the Eisai company and aimed at monitoring the performance of memory, judgment and other cognitive abilities in subjects who were administered the new drug against Alzheimer’s.

These subjects were monitored according to an 18-point scale. Their progress was quantified in half a point, compared to control subjects not treated with Leqembi.

A result that the scientists quantified as a 5-month delay in the progression of the disease.

Possible Side Effects

‘RaiNews’ reports the opinion of Joy Snider, a neurologist at Washington University in St. Louis according to whom “this drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease. That could mean for someone an extra six months to a year to be able to drive.”

And Sam Gandy of Mount Sinai Hospital focuses on the possible side effects: “Patients at greatest risk of bleeding during treatment with Leqembi are those taking blood thinners or medicines used to prevent stroke.”

This article is originally published on notizie.virgilio.it

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