The US Food and Drug Administration (FDA) approved the first Alzheimer’s treatment in nearly 20 years on Monday, despite doubts from medical experts whether the drug really works.
As explained by the FDA, aducanumab, produced by the pharmaceutical company Biogen under the brand name Aduhelm, is the first drug approved to attack the triggering process of dementia, rather than just treating its symptoms.
The regulatory agency’s decision has generated controversy in the country as an independent advisory committee and some Alzheimer’s disease specialists say there is not enough evidence that the drug can really help the sick.
The agency, while acknowledging that the clinical trial data is not yet conclusive, it considered that there was “substantial evidence” for approval.
“Although the Aduhelm data is complicated regarding its clinical benefits, 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 predict important benefits for patients, “the agency said in a statement.
However, the FDA indicated that the drug company must conduct a post-approval clinical trial to verify the clinical benefit of the drug and that it could rescind the approval if it is found to be ineffective.
“If the drug does not work as expected, we can take steps to withdraw it from the market,” he said.
What is known about the Aduhelm
Aduhelm is a monoclonal antibody given as a monthly intravenous injection intended to slow down cognitive decline in people in the early stages of the disease.
Its function seeks to eliminate deposits of a protein called beta amyloid from the brain, generally associated with the onset of dementia.
However, critics of the treatment have pointed out that while the data seem to show that it is effective in that regard, reducing amyloid is not the same as slowing dementia symptoms. The pharmaceutical company, for its part, believes that eliminating the protein from the beginning of the disease could help control its development and some doctors have supported the decision after assuring that it can be an alternative for millions of people with Alzheimer’s disease.
Although the company has not yet reported drug prices, US newspapers such as the The Wall street journal they estimate that it would cost between US $ 10,000 and US $ 50,000 per patient per year.
Why it generates controversy
The drug was approved without knowing solid data on its effectiveness and with growing criticism of its clinical studies.
And it is that during the phase III trials the company obtained contradictory results: part of the data suggested that the drug slightly slowed down cognitive decline, while the other trial did not show any benefit.
A monitoring committee then stopped the trials early after concluding that the drug did not appear to be effective.
Consequently, a third of the more than 3,000 participants did not complete the trials.
However, the pharmacist later reported that it had analyzed additional data and that, in one of the trials, a high dose of aducanumab had delayed cognitive decline by 22%.
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