• Alzheimer's, an old drug improves mental functions

  • Italian researchers discover molecule that rejuvenates the brain and blocks Alzheimer's

  • France, "wild" clinical tests on 350 Alzheimer's patients

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June 07, 2021 - The decision, which could impact millions of American seniors and their families, is sure to spark disagreements between doctors, researchers and patient groups.

It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.



The new drug, which Biogen developed with Japan's Eisai Co., didn't reverse the mental decline, it just slowed it, according to a study.

The drug is given by infusion every four weeks.

The FDA required the manufacturer to conduct a follow-up study to confirm the drug's benefits for patients.

If the study fails to prove its effectiveness, the FDA could pull the drug off the market, although the agency rarely does.



Biogen did not immediately disclose the price, although analysts estimated that the drug could cost between $ 30,000 and $ 50,000 for one year of treatment. A preliminary analysis by a group found that the drug would need a price between $ 2,500 and $ 8,300 per year to be well priced for the results.



The Institute for Clinical and Economic Review added that "any price is too high" if the drug's benefit is not confirmed in follow-up studies.



It is the first drug approved by the FDA in almost twenty years for Alzheimer's, a disease that affects millions of people and their families: almost 6 million cases in the US, 600 thousand patients in Italy alone. The FDA approved the drug on the condition that the manufacturer, Biogen, conducts further clinical trials, as the results of the first phase of testing were deemed incomplete.



These results had raised doubts about Aduhelm's effectiveness, so much so that the FDA's commission of independent advisers responsible for nerve diseases had expressed an opinion against the authorization of the drug and several experts had advised against its approval.



Aduhelm would be the first drug to intervene directly on the physiological mechanisms of the onset of the disease, namely the formation of beta-amyloid plaques on the brain. The tests showed a reduction of these plaques in patients with the first symptoms of the disease, that is memory loss and first difficulty in reasoning.



The therapy, which consists of monthly injections, has not been attempted on patients with the syndrome in an advanced state. The FDA underlines the great media attention raised by the treatment and warns that the data provided by Biogen "are extremely complex and leave residual doubts about the clinical benefits".



The US agency acknowledged that "the community of experts offered different perspectives", but explained that it had chosen the accelerated approval procedure, used to provide access to treatments for serious diseases for which there is insufficient treatment, after having concluded that "the benefits for Alzheimer's patients treated with Aduhelm outweigh the risks of the therapy."