The United States on Monday approved a drug called Aduhelm to treat Alzheimer’s patients, the first new drug against the disease in nearly two decades and the first to address the cognitive decline related to the condition.
The long-awaited Food and Drug Administration (FDA) decision is controversial as a panel of independent experts found insufficient evidence of Aduhelm’s benefit in November.
“Aduhelm is the first treatment to target the underlying pathophysiology of Alzheimer’s disease, the presence of beta amyloid plaques in the brain,” said Patrizia Cavazzoni of the FDA.
The approval of this drug has been accelerated because, according to the FDA, it provides a “significant therapeutic advance” compared to other treatments. In the United States alone there are 6.2 million patients diagnosed with Alzheimer’s.
The approved drug manages to reduce the underlying beta amyloid plaques, which are a sign of the disease, and therefore considers it “reasonable” to foresee a significant benefit for Alzheimer’s patients.
One theory holds that Alzheimer’s disease is caused by an excessive accumulation of these proteins in the brains of some people as they age and their immune systems deteriorate.
Therefore, providing antibodies to these patients could be a means of restoring some of their ability to clear plaque buildup.
“As is often the case when it comes to interpreting scientific data, the expert community has offered different perspectives,” Cavazzoni said in a statement acknowledging the controversy.
Aduhelm, a monoclonal antibody also known by its generic name aducanumab, was tested in two late-stage human trials known as phase 3 trials.
It showed a reduction in cognitive decline in one, but not the other.
In any case, and after the urgent approval, the FDA has ordered Biogen, the manufacturer of the Aduhelm, a new and larger trial confirming its benefits.
There are in the prescription of this drug, however, warnings of possible adverse effects cited by the FDA, such as inflammations that disappear with time and that do not initially cause symptoms although they can cause headaches, dizziness or nausea, as well as hypersensitivity reactions such as hives
The FDA stresses that the drug could be withdrawn if Biogen, once it does its new trial, fails to verify its benefits.
The last drug for Alzheimer’s disease had been approved in 2003, and all previous drugs have focused on the symptoms associated with the disease, not the underlying cause.
Alzheimer’s, the most common form of dementia, is estimated to affect 50 million people worldwide and generally begins after age 65.
It progressively destroys brain tissue, affecting people’s memory, leaving them disoriented and sometimes unable to perform daily tasks. It is also associated with marked mood swings and communication problems.
With information from AFP and EFE
