For the first time in nearly two decades, the US drug agency, the Food and Drug Administration (FDA), announced Monday, June 7, to authorize a new drug against Alzheimer’s disease.
“This authorization is significant in many ways”the FDA said in a statement. Called “Aduhelm” and produced by the pharmaceutical company Biogen, it is the “First approved treatment against Alzheimer’s disease since 2003”, adds the FDA.
Treatment against the causes of the disease
This is the first treatment directed against the cause of the disease, “The presence of amyloid plaques in the brain”, explains the FDA. In November, however, an expert committee ruled against authorizing this treatment, judging that it had not sufficiently demonstrated its effectiveness. A non-binding opinion, but it is rare for the FDA to dispense with it.
The committee had studied data from two studies: one large clinical trial concluded that the drug from Biogen laboratories was effective, while another had given negative results. But “The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid plaques in the brain and that reducing these plaques is reasonably likely to result in significant benefits for patients.”, she said.
The agency has thus “Concluded that the benefits (…) outweigh the risks ” of taking this drug, she added. The FDA also used a fast-track procedure that only grants the product conditional authorization, a possibility that had not been studied by the committee. “FDA asks Biogen to conduct post-authorization clinical trials to verify drug’s clinical benefits, thus specified the American regulator. If the drug does not work as expected, we may take steps to remove it from the market. “
Temper enthusiasm
The drug uses a molecule called aducanumab. These are monoclonal antibodies that aim to dissolve aggregates of this protein, beta-amyloid, which accumulates and creates plaques in the brain tissue of Alzheimer’s patients. This target is one of the main avenues explored by research against this degenerative pathology.
This drug is seen as a beacon of hope, as studies of possible treatments have suffered setbacks in recent years, and no cure exists to date. Despite everything, in accordance with the great debate that agitates the scientific community around this treatment, some experts on Monday tempered the enthusiasm.
“While I am happy that aducanumab has received approval, we need to be clear that at best this drug will have marginal benefit that will only help some carefully chosen patients., said John Hardy, professor of neuroscience at University College London. We will need better medicine in the future. “
“We are delighted with this historic decision”, reacted for its part, in a tweet, the American organization Alzheimer Association. Nearly 6.2 million Americans live with Alzheimer’s disease, which is the sixth leading cause of death in the United States but remains a disease against which research has stalled for decades. Patients with the disease gradually lose their memory, and can no longer perform daily tasks or hold conversations during the later stages of the disease.
