First-of-its-Kind Medication for Alzheimer Disease Approved By the FDA

The US Food and Drug Administration (FDA) has granted accelerated approval for aduhelm (aducanumab) a first-of-its-kind treatment for Alzheimer disease.

The accelerated approval pathway is used when a medication is found to provide a significant advantage over other approved treatments for serious or life-threatening conditions.

Aduhelm is the first treatment for Alzheimer disease approved by the FDA since 2003. It is the first of its kind to treat the fundamental pathophysiology of Alzheimer disease.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research.

“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.”

—Amanda Balbi


FDA Grants Accelerated Approval for Alzheimer’s Drug. News release. US Food and Drug Administration. June 7, 2021.