Tribune. On June 7, the Food and Drug Administration (FDA) authorized the marketing of aducanumab, a monoclonal antibody developed by the American laboratory Biogen. It had been almost twenty years since the American drug authority had approved a treatment for Alzheimer’s disease.
Some analysts welcome a landmark decision. According to them, aducanumab is a revolutionary treatment, which acts not only on the symptoms but on the disease itself, in particular on the amyloid pathology. After years of failure, this would be a huge hope for research as well as for patients and their families.
Is this enthusiasm justified? Unfortunately not yet. The authorization came as part of an accelerated procedure, which usually aims to give a chance to molecules which we have reason to believe could have an effect on a serious disease, currently without treatment. However, aducanumab was tested in two clinical trials which were stopped before their term, and whose retrospective analysis produced contradictory results. In addition, its clinical effectiveness, on cognition and functional autonomy, remains largely to be demonstrated.
A cost per patient of 47,093 euros per year
As the review points out Nature (June 8), this is not the first treatment that acts on the cause of Alzheimer’s disease; it is the first licensed treatment that attempts to treat a possible cause of the disease. Neither is it a treatment that you can get from your pharmacist; it will require a monthly intravenous infusion, close monitoring and numerous brain imaging tests. And, although the authorization was given with a very broad indication (Alzheimer’s disease), it is likely that only people with very mild cognitive disorders will be able to benefit from it.
If we add that its cost could reach 56,000 dollars per year (47,093 euros) and per patient, and that significant side effects have been observed – in particular edema and cerebral micro-bleeding -, we understand that in the United States, the vast majority of analysts severely judge its marketing.
“We can understand why investors are in a hurry to see a blockbuster put on the market that could bring in $ 5 billion per year”
In November 2020, independent experts, yet brought together by the FDA itself, unanimously voted against the authorization. The very serious American Society of Geriatrics did the same, pointing out that the balance of risks and benefits for patients was not favorable. Biostatisticians criticize the use of analyzes post hoc which, methodologically, come down to “Shoot a gun at a barn, and then paint a target around the bullet holes”. Finally, the unusually close collaboration, in this case, between Biogen and the FDA, led Public Citizen, a consumer defense group, to request the opening of an investigation.
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