Understanding What the FDA’s Accelerated Approval of Aduhelm Means for the Alzheimer’s Community

Alzheimer’s disease is pathologically defined as abnormal accumulation of amyloid plaques and tau tangles in the brain, leading to degeneration of nerve cells, memory problems, cognitive decline, and dementia. In the past two decades, we’ve watched an extremely active industry of Alzheimer’s disease clinical trials − most showing tentative steps forward with only a few appearing promising.

On June 7, 2021, early in Alzheimer’s & Brain Awareness Month, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Aduhelm (aducanumab), the first drug in 18 years for Alzheimer’s disease. The FDA then followed up by granting two other antibodies Breakthrough Therapy designation for treatment of Alzheimer’s disease. This news was long-awaited for more than 6 million Americans and more than 30 million people worldwide with the disease, one can say…

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