The US Food and Drug Administration (FDA) approved Aduhelm (aducanumab) on Monday for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans.
Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments, according to the FDA.
“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Currently available therapies only treat symptoms of the disease, while this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s, according to Cavazzoni.
