This is a first since 2003: the American Medicines Agency (FDA) has just approved the placing on the American market of a new drug against Alzheimer’s disease: Aduhelm. Produced by the Biogen laboratory, the new molecule not only treats Alzheimer’s symptoms like current treatments, but tackles the causes of the disease, namely the presence of beta-amyloid plaques in the brain. However, its effectiveness remains questioned by part of the scientific community, which calls for caution.
The first treatment against the causes of the disease
Alzheimer’s disease is, to date, the most common cause of dementia, affecting more than 7% of the world’s population, most often elderly. Neurodegenerative disease marked by an alteration of neurons, it slowly and progressively destroys certain cognitive functions such as memory, language and leads to behavioral disorders. Two types of lesions form in patients with the disease. One, amyloid plaque or senile plaque, is an abnormal buildup of proteins between neurons and the other, tau protein, is formed when fibers inside neurons become intertwined causing neurofibrillary degeneration.
To date, although there is no effective cure to fight against this degenerative disease, two groups of drugs are used in the treatment of Alzheimer’s: anticholinesterases and antiglutamates which act on memory and brain disorders. behavior, but not on the progression of the pathology.
This new drug therefore represents real hope for patients and their families.. It uses a molecule, Aducanumab. It is a monoclonal antibody whose objective is to cause the dissolution of senile plaques (amyloid plaques) which accumulate in the brain tissues of patients and gradually destroy the brain. This injectable treatment can only be administered during the first symptoms, at the mild stage of the disease, hence the importance of early detection of the disease.
Results, however, still inconclusive
Last November, a committee of independent experts from the FDA issued a negative opinion on the authorization of this treatment, for lack of tangible evidence on its effectiveness. The committee relied on two studies with contradictory results. The first had concluded that the drug was effective and would significantly reduce amyloid plaques, the second had given negative results.
The FDA did not disregard this opinion and decided, despite everything, to authorize the sale of the drug, considering that the “Expected benefits are greater than the risks”.
However, preferring to play the card of safety, the FDA preferred to use a fast-track approval procedure reserved for drugs treating “A serious or potentially fatal disease and offering a significant therapeutic advantage over existing treatments” by only granting a conditional release authorization for the product, an alternative that the committee had not studied.
The Biogen laboratory must now conduct post-authorization studies to verify the beneficial effects of its drug, otherwise the FDA could have to withdraw it from the market.
If the arrival of this drug was greeted with certain reservations, many still hope that the authorization of this treatment is not the result, but rather marks the beginning of a new dynamic in research to fight Alzheimer’s disease.
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