FDA Approves First New Alzheimer’s Drug in Nearly 20 Years

There’s good news for people in the early stages of Alzheimer’s disease.

For the first time in nearly two decades, the Food and Drug Administration (FDA) has approved a drug to slow the progression of the disease.

“Aducanumab is what’s called a monoclonal antibody, it’s an IV-infused manufactured protein that actually is supposed to find the amyloid in the brain and the body and grab it and remove it,” said Marwan Sabbagh, MD, Director of Translational Research at Cleveland Clinic Lou Ruvo Center for Brain Health, who took part in the drug trials.

Amyloid is a protein that forms in the brain and over time creates plaques which are believed to damage brain structures, leading to what we know as dementia.

This new drug targets amyloid and removes it during the very beginning stages of Alzheimer’s to slow damage to the brain.

It doesn’t reverse damage that’s already been done or improve symptoms, but it may give people more time before advanced dementia sets in.  

This new drug is given through an infusion. (Courtesy: Cleveland Clinic)

“We in the field have been waiting, not just physicians and scientists, but patients and caregivers have been waiting for some really impactful treatment,” said Dr. Sabbagh. “I want to overemphasize that this drug does not make people better but it does slow the decline.”

“This is an exciting time in our field. This is a turning point and opens the door to a new way of treating and preventing Alzheimer’s disease,” said Babak Tousi, MD, head of the Clinical Trials Program at Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland.

More than 6 million Americans are living with Alzheimer’s disease, according to the Alzheimer’s Association. Millions of patients will be eligible for this new treatment.

*EDITOR’S NOTE: Dr. Sabbagh and Dr. Tousi are paid scientific advisors for Biogen, the company that makes Aducanumab.