It is a hope that came to America this week for all people with Alzheimer’s disease, an incurable neurodegenerative disease that causes the progressive and irreversible loss of mental functions and especially memory.
In France, according to the French Alzheimer’s Association, 1.2 million people are affected by this disease, 35,000 of them under 65 – because this disease is by no means just an illness of “old people”, as is believed.
For all of these patients and their families, the American Medicines Agency (FDA) gives the green light to the Biogen pharmaceutical laboratory that manufactures Aduhelm important. “We are delighted with this historic decision,” responded the American Alzheimer Association. “It is the first FDA-approved drug that slows the decline due to the disease,” President Harry Johns said in a statement.
In November, however, a panel of experts decided against the approval of this treatment because it had not sufficiently proven its effectiveness. A non-binding opinion that the FDA seldom waives. The committee had examined data from two studies: one large clinical study concluded that the drug from the Biogen laboratories was effective, while another gave negative results.
But the FDA concluded that there are benefits […] outweigh the risks of taking this drug. In addition, an accelerated process was used that only gives the product conditional approval – a possibility that the committee has not investigated. “The FDA is asking Biogen to conduct post-approval clinical trials to review the drug’s clinical utility,” the US regulator said. “If the drug doesn’t work as expected, we can take steps to take it off the market. “
This green light surprised the international medical community. In the United States, doctors have announced their intention not to prescribe this drug, which is given under a very restrictive protocol: it must be given intravenously with brain imaging at an early stage in unaffected patients, and it can have significant side effects.
“This green light is based on data from a study that was discontinued due to lack of effectiveness. Subsequent analysis suggests that the molecule could have an effect at high doses. It would have been more sensible to be sure to do a new clinical study, ”said in Le Figaro Professor Sarazin, head of the neurology department of the Sainte-Anne hospital (Paris).
The fact is that this approval, which makes Aduhelm the first drug against Alzheimer’s disease approved in seventeen years, is a major step forward. “It’s a real hope because it shows that there is research in the world of Alzheimer’s disease, drugs being tested, and some of them end up getting marketing approval, but there are certain conditions that need to be specified,” explains Pr. Amouyel. Managing Director of the Alzheimer’s Foundation, to France Info. But the specialist remains cautious and waits for “further studies”.
$ 56,000 per patient per year
The FDA’s decision could speed things up on the European Medicines Agency’s part, allowing the drug to be available to the French in a matter of weeks or months.
Biogen’s shares are up 38% after the FDA gives the go-ahead. Analysts point out that Aduhelm could generate annual sales of up to $ 5-10 billion – the average cost of treatment is $ 56,000 per patient year. But the launch of this drug could also “fuel the sector, increase investment in new treatments and drive innovation” for Maria Carrillo, scientific director of the Alzheimer’s Association.