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New Alzheimer drug approved: Aduhelm by the Biogen laboratory

Aduhelm, produced by the Biogen laboratory, is the first Alzheimer's disease drug to have received marketing approval in the United States since 2003.

It is also the first to address the causes of the disease.

But for some in the scientific community, its benefit for patients has not been demonstrated.

This is a first in nearly 20 years.

On Monday, June 7, U.S. health authorities authorized a new Alzheimer's disease drug manufactured by the Biogen laboratory.

New Alzheimer drug approved: Aduhelm by the Biogen laboratory

Baptized Aduhelm, this antibody-based treatment was eagerly awaited by patients' associations who had not seen anything new since 2003.

However, the release of the drug has been greeted with dismay by a part of the scientific community, which fears that the FDA may have been too quick to act.

FDA: the Food and Drug Administration, the American drug regulator.


New drug: attacks disease supposed origin

Until now, all available drugs have been aimed at treating the symptoms of this disease and have sought to alleviate them.

Those symptoms include progressive memory loss and difficulties in expressing oneself or thinking.

The treatment would get to the root of the problem, potentially slowing the degenerative process.

It would offer a new ray of hope to more than 30 million Alzheimer's patients worldwide.

 

"From a biological point of view, according to Vincent Planche, an Alzheimer's specialist and clinician at the University of Bordeaux.:

The results of Aduhelm are quite spectacular.

The antibody does exactly what it is asked to do, that is to say, it destroys the amyloid plaques in the brain.

These plaques, created by the accumulation of beta-amyloid proteins produced in the brain.

They have been the main suspect in the development of Alzheimer's disease since the early 1990s.

We speak of amyloid cascades to designate this hypothesis explaining the disease," explains Vincent Planche.

According to this dominant theory, amyloid plaques play the role of a trigger that acts on another substance in the brain.

These are the tau proteins, which are responsible for doing the dirty work of "neuron assassins", explains Tara Spires-Jones.

The administration of antibodies can also have significant side effects.

There have been cases of hemorrhages and strokes, as well as encephalitis, which has led to the discontinuation of several clinical drug trials.


The cost of the New Alzheimer's drug

This data is according to the Financial Times, the decision of the laboratory Biogen, which makes this drug.

It is to position in terms of price this drug at 56,000 dollars per year.

This is the price of new drugs that use these methodologies, in particular these biotherapies.

The biotherapies require extremely regular injections, every month, of these famous antibodies that are extremely expensive to produce.

Now, we will have to phase in its effectiveness.


Controversial results of Aduhelm

Biogen's Aduhelm passed this test and was deemed "safe" after two phases of clinical trials.

This is one of the reasons why the American FDA granted it a marketing authorization.

Specifying that the "expected benefits are greater than the risks".

But the problem is that the benefits for patients are far from being established with certainty.

The committee of scientific experts convened to advise the FDA on the approval had also given a negative opinion on its marketing.

First, Aduhelm had very positive effects on animals.

Biogen then moved on to the human testing phase, changing the protocol several times, "which is never a good sign," notes Vincent Planche.

The laboratory conducted two trials over 18 months with nearly 4,000 participants and provided intermediate results to an independent analysis center.

The latter gave a very severe verdict, judging that the drug "did not bring any benefit" to patients.

But Biogen later retrieved the results, added additional data from the trials and reported that one of the tests.

In which patients received a large dose of the antibody, showed a slight improvement in symptoms.

This is probably what convinced the FDA, under pressure from patient associations, to override the recommendations of its own expert committee.

The drug regulator has, however, ordered Biogen to conduct a new clinical trial to confirm the data.

That leaves open the possibility of withdrawal of approval in case of disappointing results.


Explore more Aduhelm by the Biogen laboratory

But for many experts, the damage is already done. Several experts give their statements:

  • John Harding:

The FDA's green light will give the impression of new hope to millions of patients.

"It must be clear that this drug will, at best, provide a small benefit to a small number of hand-picked patients".

  • Tara Spires-Jones:

"The FDA press release does not indicate at what stage of the disease this treatment is supposed to be effective, which is rare."

  • Vincent Planche:

It is a drug for patients at "a very early stage of the disease when there are not yet too many amyloid plaques".

  • Tara Spires-Jones:

The problem is that "often when patients feel the first symptoms, it is already too late".

Aduhelm could therefore be an effective drug, especially for patients who are unaware of it...

Sylvie Lorthois, a biomechanic at the CNRS who has worked on Alzheimer's disease.

The FDA's decision may also give the impression that acting on amyloid plaques is the only valid avenue of research.

 "Whereas there are still many things we are not sure about in the functioning of this disease."

For her, the fact that Aduhelm succeeds in reducing amyloid plaques without having a clear effect on symptoms should push scientists to explore other avenues.

Ultimately, the solution could come from a combination of treatments that act on both the plaques and other factors.

That is including tau protein or blood flow problems in Alzheimer's patients.

In short, she hopes that the approval of this treatment is not the end of the road, but rather the beginning of a new dynamic.

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