A drug capable of slowing the course of Alzheimer’s during the early stages of the disease. Is called Aducanumab, is produced by the pharmaceutical company Biogen, and aims to act on triggering causes of the disease (and not its symptoms) by slowing its progression. The green light has come in these hours from Food and Drug Administration, the US government agency that deals with the regulation of pharmaceutical products. It is the first new drug against l’Alzheimer approved by 2003, even if his authorization was far from shared. The difficulties are due to the fact that many independent consultants of the same agency have spoken out against the therapy, saying that the treatment has not been shown to help slow the disease.
In particular, opponents focus on the fact that no one was ever conducted before the drug was approved follow-up study to confirm the benefits of the drug for patients. Thus, to address this “lack”, it was the FdA itself that requested the pharmaceutical company (and the Chinese developer who collaborated in the creation of the drug, the company Eisai Co) to conduct further investigations so as to confirm the benefits. If this is not the case, the institution could also withdraw the drug from the market.
The approved protocol provides that the Aducanumab, which is in fact a monoclonal antibody, is given by infusion every four weeks. As mentioned, this is the first drug which intervenes directly on physiological mechanisms the onset of the disease, or the formation of betamyloid plaques on the brain. In patients with the first symptoms of the disease, that is memory loss and first difficulties in reasoning, the tests carried out by Biogen and subjected to the FdA have shown a reduction of these plaques and therefore of the symptoms. However, the therapy has not been tested on patients with advanced syndrome. The agency itself points out that the data provided by Biogen “are extremely complex and leave doubts on clinical benefits “. Again the FDA acknowledged that “the community of experts offered different perspectives”, but explained that it had chosen the accelerated approval procedure because “the benefits for Alzheimer’s patients treated with Aduhelm they exceed i risks of therapy “.
Ultimately, Biogen did not disclose the price of the drug, although analysts have estimated that the could fluctuate between 30.000 e i 50.000 dollars for one year of treatment. A preliminary analysis instead found that the drug would need a price between 2,500 and 8,300 dollars per year to be congruent with the results. L’Institute for Clinical and Economic Review he added instead that “any price is too high”If the benefit of the drug is not confirmed in the follow-up studies.