Adohelm drug reduces beta-amyloid plaques in the brain (AFP)
The agency indicated in a statement on Monday that the drug, called “Adohelm” and produced by the “Biogene” company for pharmaceutical industries, is “the first treatment against Alzheimer’s disease that has been approved since 2003.”
And the “FDA” pointed out that this treatment is the first that addresses the mechanism of the disease itself, that is, “the presence of beta-amyloid plaques in the brain”, and not only the symptoms caused by it.
The American Alzheimer’s Association called the decision “historic.” “This is the first drug to be approved by the FDA to slow the relapse caused by the disease,” its president, Harry Jones, said in a statement.
This decision comes despite the announcement by an expert committee in November that it did not support allowing this treatment, arguing that its efficacy had not been sufficiently proven, in a non-binding position, but it is rare for the FDA to override it.
The committee had analyzed the data of two studies: a large-scale clinical trial concluded that the drug “Biogene” laboratories was effective, while another led to negative results.
However, the “FDA” said that it “has found compelling evidence that Adohelm reduces beta-amyloid plaques in the brain, and reducing these plaques logically bears significant advantages for patients.” The agency concluded that “the benefits outweigh the risks” of taking this drug.
The FDA has also adopted an expedited course that grants the drug only conditional authorization, a possibility that the committee did not consider.
And the “FDA” asked “Biogen” to conduct clinical trials after granting permission, to verify the clinical benefits of the drug, according to the US Agency, which said, “If the result of the drug is not as expected, we may take measures to withdraw it from the market.”
About six million Americans suffer from Alzheimer’s disease, which is the sixth most common cause of death in the United States. This disease gradually strikes the memory of patients who, in its later stages, become unable to carry out daily tasks or engage in discussions.
The FDA confirmed that “the need for treatment is an emergency.” “I think we have received clear positions from patients confirming their willingness to face some ambiguity in exchange for obtaining a drug that may produce important results,” agency official Peter Stein said during a press conference. The drug will cost about 56 thousand dollars annually for an American of average weight, according to what the manufacturer announced on Monday. The reimbursement of the price depends on the health coverage that the person enjoys.
The drug uses a molecule called aducanumab. They are monoclonal antibodies that aim to dissolve the scales of this protein, beta-amyloid, which accumulate and lead to plaques in brain tissue in Alzheimer’s patients.
This goal is among the main tracks in research aimed at addressing this degenerative disease.
However, studies on treatments have faced successive setbacks in recent years, and no treatment has led to a cure for Alzheimer’s patients until today.
That is why this treatment, which is taken once every four weeks by intravenous injection, is seen as a glimmer of hope.
But some experts were not enthusiastic about this treatment, which reflects the great controversy surrounding it in the scientific community.
John Hardy, professor of neurosciences at University College London, said: “While I am pleased with the license aducanumab has received, we must be clear that this drug will at best have marginal benefits that will only help a few carefully selected patients.”
“We will need better medicines in the future,” he added.