FDA approves aducanumab for treatment of Alzheimer's disease

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 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.” 

Chin emphasizes that aducanumab will not prevent Alzheimer’s disease and encourages people to learn about and follow prevention strategies that can improve brain health and lower risk for developing Alzheimer’s disease. 

It is important to note there are other causes of mild cognitive impairment and dementia. If a person has one of these non-Alzheimer’s disease causes, the drug will not be helpful or an option for treatment. "People should discuss their diagnosis and suspected cause with their providers," Chin says. "And most importantly, people should continue to build a strong network of support and care because this drug is not a silver bullet."

Learn more about aducanumab from the FDA:

• news release about the aducanumab approval
• statement from Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research

The aducanumab approval has been celebrated by some and criticized by others. The New York Times wrote about the controversy in its article “F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works” (published June 7, 20201).

Frequently Asked Questions

 What does aducanumab do?

 It attaches to beta amyloid proteins in the brain and removes them.

Who can receive this treatment?

The FDA has approved this drug for people with Alzheimer’s disease. Eligible patients must have confirmed amyloid in their brains to be considered for this treatment. While doctors can prescribe this treatment for any stage of cognitive impairment, a thorough discussion is needed to determine the benefits and risks.

How is the drug administered?

Through an infusion. The infusion will take approximately 1 hour and will occur every 4 weeks.

How much does aducanumab cost?

Biogen announced a list price of $56,000 per year.

When will it be available to patients?

We do not know at this time. An infrastructure will need to be built so that the medication can be properly administered and patients can be properly followed afterward.

Are there side effects?

The most common side effects were brain swelling and bleeding, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.