This is a first in almost two decades. The US Drugs Agency (FDA) on Monday announced it would authorize a new drug for Alzheimer’s disease. Named Aduhelm and produced by the pharmaceutical company Biogen, it is the “first approved treatment against Alzheimer’s disease since 2003,” said the US regulator in a press release.
- Why was this medicine authorized?
In November, however, an expert committee ruled against the authorization of 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 the contradictory data of two studies: one large clinical trial had concluded that the drug from Biogen laboratories was effective, while another had given negative results. Biogen, Supporters Explain Second Trial Success With Larger Doses, Says The echoes. The skeptics consider them that it is a fluke, whereas many laboratories have previously explored this avenue without success, or with molecules proving to be too toxic.
But “the FDA has determined that there is substantial evidence that Aduhelm reduces beta-amyloid plaques in the brain and that reducing these plaques is reasonably likely to result in significant benefits for patients,” a- she declared. The Agency thus “concluded that the benefits (…) outweigh the risks” of taking this drug.
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Nearly six million Americans live with Alzheimer’s, which is the sixth leading cause of death in the United States. The disease gradually robs the memory of affected patients, who in the later stages of the disease can no longer perform daily tasks or hold conversations. “The need for treatment is urgent,” hammered the FDA. “I think we have clearly heard from patients that they are ready to accept a certain uncertainty in order to have access to a drug which could produce significant effects”, argued Peter Stein, head at the Agency.
All is not yet done for the Aduhelm. The FDA used a fast-track procedure that only grants the product conditional clearance – a possibility that was not considered by the committee. “The FDA asks Biogen to conduct post-authorization clinical trials to verify the clinical benefits of the drug,” said the US regulator. “If the drug does not work as expected, we can take steps to take it off the market,” he said.
- How does it work ?
It is the first drug directed against the disease mechanism itself, “the presence of beta-amyloid plaques in the brain,” and not just the symptoms it causes, the FDA noted. The drug uses a molecule, called aducanumab. Monoclonal antibodies aim to dissolve aggregates of the beta-amyloid protein, 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. But treatment studies have suffered setbacks in recent years, and no cure exists to date. This is why this drug, administered intravenously every four weeks, was seen as a silver lining.
The cost of the product will come to about $ 56,000 per year for an average weight American, the company said Monday, and its reimbursement will depend on the health coverage each patient has purchased.
- Is there hope for patients?
“We are delighted with this historic decision”, reacted the American organization Alzheimer Association. “It is the first drug approved by the FDA to slow the decline due to the disease,” President Harry Johns said in a statement.
“It’s a real hope because it shows that in the world of Alzheimer’s, there is research, there are drugs being tested and some of them end up having a marketing authorization, but it should be specified, under conditions “, also reacted to Franceinfo professor Philippe Amouyel, director general of the Alzheimer Foundation and professor of public health at the University Hospital of Lille.
In accordance with the great debate which agitates the scientific community, certain experts thus wished to moderate the ambient enthusiasm. “While I am happy that aducanumab has received clearance, 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 drugs in the future,” he added.
For Maria Carrillo, the scientific director of the Alzheimer Association, this is precisely what the authorization of the FDA will allow to aim: “History has shown that an authorization of a first drug of a new category was stimulating the industry, increasing investment in new treatments and encouraging innovation, “she said, while Alzheimer’s remains a disease against which research has stagnated for decades.
LEXPRESS.fr with AFP
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The action of Biogen in any case jumped on the stock market on Monday, amounting to + 38.34% after the closing of Wall Street. It had been temporarily suspended in the morning to avoid too much volatility. As specified The echoes, other laboratories working on this disease have also seen their share prices rise. Lilly’s thus took 13%, and biotechs such as Cassava Sciences or Annovis Bio saw theirs rise by 19% and 31% respectively. Analysts also estimate the potential annual turnover of the Aduhelm at five billion dollars.
LEXPRESS.fr with AFP
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