The Food and Drug Administration (FDA) on Monday approved what it described as a “first-of-its-kind” treatment for Alzheimer’s disease, which it says “targets the fundamental pathophysiology of the disease.”
The approved drug, aducanumab, is what the Washington Post described as the “first drug cleared that is designed to alter the course of the disease by slowing the deterioration of brain function — not just to ease symptoms.”
“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,” the FDA said in a Monday statement:
We recognize the unmet medical need for patients with Alzheimer’s disease, the devastating nature of the disease for patients and their families, and the urgency to make treatment available.
— U.S. FDA (@US_FDA) June 7, 2021
Researchers evaluated Aduhelm’s efficacy in three separate