Because there is so much talk about aducanumab, the Alzheimer's drug approved in the US

Because there is so much talk about aducanumab, the Alzheimer's drug approved in the US

Because there is so much talk about aducanumab

The Food & Drug Administration has given the green light to an Alzheimer's drug with a troubled clinical history. The evidence of clinical efficacy, in fact, would not be so clear, even if it would be able to reduce the amyloid plaques associated with the disease

(photo: Steven HWG on Unsplash) Born and raised with the best hopes, abandoned with regret, resurrected and finally approved. In a nutshell, this is the story of aducanumab (Aduhelm), the drug just approved by the Food And Drug Administration (Fda) for the treatment of Alzheimer's. The first since 2003, the first to target the underlying processes of the disease. And this would be enough to make it a milestone in the fight against the disease, studded with various failures, in the arduous search for a cure. But the approval of aducanumab has generated understandable excitement on the one hand - Alzheimer's is now a devastating degenerative disease, a form of dementia affecting tens of millions of people worldwide - on the other it has been met with skepticism, and some fear. Why?

That of aducanumab is a troubled story. In fact, the drug has been talked about for some time: it is a monoclonal antibody that targets the beta amyloid plaques of the central nervous system, one of the biological characteristics associated with Alzheimer's disease, together with the neurofibrillar clusters of the tau protein. The first analyzes on a limited number of patients had shown that the drug was capable, in a dose dependent manner, of reducing amyloid plaques and was also associated with cognitive improvement. But hopes of replicating and confirming findings in larger studies, as expected, were then shattered when shortly thereafter, Biogen and Eisai, the companies behind the drug's development, announced the discontinuation of phase three trials due to lack of evidence. of effectiveness. Not long after, however, new analyzes on the same studies, according to the companies, in favor of the drug's usefulness, would have led to the FDA being asked for authorization of the drug, not without perplexity. And today those same studies - conducted on patients with mild disease - are cited as a source of evidence to support FDA approval. But it is the FDA itself that defines the limits and the context of the drug's approval.

Aducanumab is a monoclonal antibody to be taken by infusion, once every four weeks, for an annual cost of 56 thousand dollars, with effects collateral such as temporary cerebral edema, associated or not with bleeding, without symptoms, or with headache, confusion, dizziness, nausea, as well as hypersensitivity reactions. It got the go-ahead from the FDA through an accelerated approval process. A path reserved for serious illnesses and with unmet needs but with some caution. According to the FDA, in fact, we know that aducanumab reduces amyloid plaques, but this in itself is not a measure of clinical benefit. Patrizia Cavazzoni, head of the Fda Center for Drug Evaluation and Research, remarks this in a long note on the sidelines of the news of the approval, in which she tells how and why this decision was reached, despite doubts and skepticisms about the real effectiveness of the drug . "As often happens when it comes to interpreting scientific data, the community of experts has offered different perspectives," he writes, and we could not possibly understand it better after more than a year of pandemic.

But back to aducanumab: that it seems certain that the drug does reduce amyloid plaques, but whether this actually translates into cognitive improvements is not clear. It is something “expected”, “reasonably probable”, writes Cavazzoni, but not proven, in the face of data that are not entirely unequivocal and complicated. To the point that the Peripheral and Central Nervous System Drugs Advisory Committee did not consider the data sufficient to prove the benefits of the drug, which the FDA eventually agreed, considering the impact of the disease and the need, especially on the part of patients. , to find something. But there are those who see in this precisely the risk of the FDA's move, taken in a context of so declared uncertainty, with patients inclined to listen only to the potential benefits of the drug, as a clinician tells the New York Times referring to his own. experience. The post-approval trial asked of the companies behind the drug will help to clarify and could revise everything once again.

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