By Pamela Cruz
The Food and Drug Administration ?FDAapproved a drug called Aduhelm on Monday, the first to address Alzheimer's-related cognitive decline.
The drug was approved using the accelerated route, to which they resort in the case of "a specific medicinal product for a serious or life-threatening disease that provides a significant therapeutic advantage over existing treatments".
"Alzheimer's disease is devastating and can have a profound impact on people's lives not only for those affected but for their loved ones," explained Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research.
The specialist explained that currently available therapies only treat the symptoms of the disease; "this drug option is the first therapy that targets and affects the underlying disease process of Alzheimer's disease.
He added that after learning from the fight against cancer, the accelerated approval pathway can bring therapies to patients more quickly while spurring more research and innovation.
Alzheimer's is a progressive, irreversible brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to perform simple tasks.
Although its specific causes aren't fully understood, Alzheimer's disease is characterized by changes in the brain, including amyloid plaques and neurofibrillary tangles, or tau, which cause the loss of neurons and their connections. These changes affect the ability to remember and think.
A light in the long tunnel
Although long-awaited, the decision has caused controversy after a panel of independent experts last November found insufficient evidence of Aduhelm's benefit.
Aduhelm, manufactured by Biogen of Cambridge, Massachusetts, was evaluated in three separate studies in a total of 3,482 patients.
These results supported its accelerated approval, which is based on the surrogate endpoint of reduction of beta-amyloid plaque in the brain, a hallmark of Alzheimer's disease.
Under the accelerated approval provisions, which gives patients earlier access to treatment, the FDA requires Biogen to conduct a new randomized controlled clinical trial to verify the drug's clinical benefit.
If the trial fails to prove clinical benefit, the FDA may initiate proceedings to withdraw approval.
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