FDA approves aducanumab for Alzheimer’s disease treatment

On June 7, the U.S. Food and Drug Administration (FDA) approved the drug aducanumab for the treatment of Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s disease since 2003 and the first-ever approved treatment to target an underlying cause of Alzheimer’s disease rather than manage symptoms. Aducanumab is also known by the brand name Aduhelm and is made by Biogen.

While the FDA did not give a full approval, it has proceeded to allow aducanumab to be used in clinical settings. If the drug is not shown to be effective in this “real world” setting, the FDA can remove its approval.

“Aducanumab is not a cure for Alzheimer’s disease and will not stop the progression of the disease,” says Nathaniel Chin, MD, medical director for the Wisconsin Alzheimer’s Disease Research Center (ADRC). “But the data from one of the main studies show it offers a 22% reduced decline in cognitive and functional changes over 18 months.”

Read more about the drug, Dr. Chin’s perspective on its approval, and answers to frequently asked questions about it on the Wisconsin ADRC news page.