The FDA’s green light for the Alzheimer’s drug aducanumab, arrived today, comes after twenty years of research failures in this field, and certainly increases the hopes of millions of patients around the world, so far frustrated by hundreds of stop to therapies considered promising. According to the American body, which in any case requested a new clinical test, the therapy developed by Biogen has the potential to slow down the course of the disease. The FDA’s decision was made despite opposition from the agency’s independent panel of experts and other Alzheimer’s experts that there is not enough evidence to show that the drug can really help patients.
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How the therapy works
The therapy consists of one intravenous injection per month which in the Alzheimer’s therapy would help slow down the cognitive decline of patients who are at the initial stage of the disease. This is the first treatment that affects the course and is not limited to attacking the symptoms of dementia. “We are aware of the attention surrounding this approval – said Patrizia Cavazzoni, who heads the FDA Center for Drug Evaluation and Research -. We know that the therapy has generated the attention of the press, patients and many interested parties ».
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The sacred Grail
Alzheimer’s therapy has emerged in recent years as the ‘holy grail’ of medicine. Still in 2018 an editorial in Jama had surveyed 400 failures of clinical trials on humans of potential therapies, with several multinationals who had decided in the course of work to abandon research in this field altogether, and in the following years things did not go better. The adacanumab test itself was considered to have failed at first, before further analysis showed some benefit on early-stage disease.
The numbers of the sick in Italy
Currently, according to the website of the Ministry of Health, the total number of patients with dementia is estimated at over 1 million (of which about 600,000 with Alzheimer’s dementia) and about 3 million people are directly or indirectly involved in their care, with consequences also on the economic and organizational level. The problem is obviously not only Italian. In 2010 35.6 million people were affected by dementia with an estimated double increase in 2030, triple in 2050, with 7.7 million new cases per year (1 every 4 seconds) and with an average survival, after the diagnosis, 4-8 years old.
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Experts: “Historical day”
«Today is a historic day – commented virologist Roberto Burioni on Twitter -. The first effective drug against Alzheimer’s disease has been approved by the FDA ». “It is the first drug in twenty years that seems to be able to help the sick, but it will not be for all people affected by Alzheimer’s,” explains Paolo Maria Rossini, director of the Department of neuroscience-neurorehabilitation at Irccs San Raffaele in Rome. «This new drug» continues Rossini, «is the first able to interfere with one of the many ‘killers’, the beta-amyloid protein but as far as I remember it has potential side effects such as cerebral microhemorrhages. Who will do it (I estimate about 100,000 candidal patients in Italy if Ema and Aifa are approved) will have to undergo magnetic resonances and have documented the presence of beta-amyloid protein “.
“The first able to interfere with one of the many ‘killers'”
The anti-Alzheimer monoclonal antibody approved in the US after almost twenty years «unlike the last two drugs which affected only some symptoms, modifies the natural course of the disease and its progression. It is the first drug in twenty years that seems to be able to help the sick, but it will not be for all people affected by Alzheimer’s ». Paolo Maria Rossini, director of the Department of neuroscience-neurorehabilitation at Irccs San Raffaele Rome, explains this to Adnkronos Health. “However, it is remarkable news – he adds – when science breaks down a door, then really important roads open up”. “This new drug is the first capable of interfering with one of the many ‘killers’, the beta-amyloid protein but as far as I remember it has potential side effects such as cerebral microhemorrhages – warns Rossi – Who will do it, I estimate about 100 thousand patients in Italy candidates if there is the approval of the Ema and Aifa, will have to undergo magnetic resonances and have documented the presence of the beta-amyloid protein. For example, a person cannot take insulin without having a high blood sugar. Therefore frequent checks and examinations are necessary ».