June 8, 2021

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

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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.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 81,000 employees worldwide are more than 5,743 salaried physicians and researchers, and 20,160 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,690-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 276 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2023, there were 13.7 million outpatient encounters, 323,000 hospital admissions and observations, and 301,000 surgeries and procedures throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 132 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/CleClinicNews. News and resources available at newsroom.clevelandclinic.org.

Editor’s Note: Cleveland Clinic News Service is available to provide broadcast-quality interviews and B-roll upon request.

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