The news was welcomed with hope by the Vaincre Alzheimer foundation: the treatment to slow down cognitive decline in patients with Alzheimer’s disease, developed by the Biogen laboratory, has just obtained marketing authorization. market with the US Food and Drug Administration (FDA). This treatment, aducanumab, would thus be the first to be able to slow down the development of the disease, taken at an early stage.
The slowing of cognitive decline has indeed been shown in people with mild cognitive impairment (MCI) and early-stage Alzheimer’s disease.
A treatment that slows clinical decline by 23%
This treatment, called Adulhem, does not stop the neurological evolution of Alzheimer’s disease but it is the very first immunotherapy that modulates the biological processes of the disease. By eliminating the deposits of beta-amyloid protein that accumulate in the diseased brain, the treatment slows clinical decline by 23%, according to two studies carried out by the laboratory.
“Even though Adulhem does not improve cognition or halt the neuroevolutionary process, this milestone shows that research is moving forward and beginning to bear fruit. This breakthrough is the result of more than 35 years of medical research and of progress that began since the discovery of the beta-amyloid protein in 1984” emphasizes Dr. Maï PanchalScientific Director of the Vaincre Alzheimer Foundation.
An authorization which remains provisional
Aduhelm was approved using the accelerated approval pathway, says FDA in a press release. This procedure can be used for a drug for a serious or life-threatening condition that offers a significant therapeutic advantage over existing treatments. But scientists will have to conduct a study “post-approval” to verify that the drug provides the expected clinical benefit. If this new trial fails to show clinical benefit, the FDA may withdraw the drug’s approval.
When will the treatment be approved in France? As with any new treatment, the European Medicines Agency will in turn have to give its opinion, which may take a few weeks or even a few months. “I think that the decision of the American regulations risks speeding up the procedures. But I am in favor of first demonstrating that this drug does indeed have clinical activity. Which would perhaps take a few months or years of trying” suggests Philippe Amouyel, CEO of the Alzheimer Foundation and professor of public health at the University Hospital of Lille, on France Info.
In video: the explanations of Pre Claire Paquet, neurologist at the Lariboisière hospital (Paris)
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