Story at a glance
- The FDA announced a fast-track treatment for Alzheimer’s disease for the first time in nearly two decades.
- A form of dementia, Alzheimer’s is a common disease without a known cure.
- The condition affects over 6 million Americans.
On Monday, the U.S. Food and Drug Administration (FDA) approved a treatment for Alzheimer’s disease, which affects an estimated 6.2 million Americans.
The treatment, Aduhelm, was approved via the FDA’s accelerated approval pathway, which is granted to drugs based on the conclusion that it is likely to benefit a patient, and will eventually undergo a post-approval clinical trial to verify its benefits.
“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a release. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”
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Alzheimer’s is a type of dementia that progressively deteriorates the parts of the brain responsible for thought, memory and language, leading to memory loss and other diminished cognitive functions, and tends to affect people aged 60 and older
Aduhelm has been under FDA consideration for approval since November 2020, when it was reviewed in a committee meeting. Prior to FDA approval, researchers evaluated Aduhelm based on its application in three separate studies. In gauging Aduhelm’s effects, researchers looked at the amount of amyloid beta plaque in the brain, a key sign of Alzheimer’s.
FDA officials noted that upon prescription, Aduhelm will carry the warning for temporary brain swelling, which can bring side effects including headache, confusion, dizziness, vision changes or nausea.
There is still no known cure for Alzheimer’s disease.
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