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Alzheimer’s Association Welcomes U.S. FDA Traditional Approval of Leqembi: Full Details

Alzheimer’s Association Welcomes U.S. FDA Traditional Approval of Leqembi: Full Details
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July 6, 2023
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CHICAGO, July 6, 2023 — The Alzheimer’s Association celebrates today’s U.S. Food and Drug Administration (FDA) action to grant traditional approval of Leqembi® (lecanemab, Eisai/Biogen) for the treatment of early Alzheimer's disease with confirmation of elevated amyloid beta. This is the first traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease.

“This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “While we continue efforts to discover new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment is right for them.”

Leqembi works by targeting amyloid beta, the primary component of amyloid plaques, which are a disease-defining hallmark in the brains of people with Alzheimer’s disease. Well-conducted clinical trials clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer’s. In a Phase 3 clinical trial, Leqembi delayed cognitive decline by 5.3 months compared to placebo after 18 months of treatment, at a time when such delays are most valuable to the individual. Further delays in progression are anticipated with extended time under treatment. It is administered twice monthly through intravenous infusion. Leqembi has been on the market since January 2023, when it received accelerated approval from the FDA. However, to this point access has been blocked by Medicare coverage policies.

“This is a momentous day for people living with early-stage Alzheimer’s and their families,” said Hugh Courtney, 60, of Concord, Mass., who was diagnosed with Alzheimer’s disease in 2020. “I was in the Leqembi clinical trial, so I am really excited about today’s FDA approval. It gives others living with early-stage Alzheimer’s a chance to pursue treatment that may slow progression of their disease.”

With FDA-approved treatments now available, it is more important than ever that patients and their families have informed discussions with their health care providers about the potential risks and benefits of treatments.

The FDA included a boxed warning in Leqembi’s label to raise awareness about specific side effects and at-risk populations. Side effects include amyloid-related imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolves over time. ARIA does not usually cause symptoms but in a low number of cases can be serious. The FDA also recommended, but did not mandate, genetic testing. People with two copies of a well-known Alzheimer’s risk gene may be more at risk of ARIA. 

“The FDA’s consideration in the label will help ensure clinicians monitor safety closely — this is a good thing. However, the boxed warning should not keep clinicians and patients from having the conversation about the benefits and risks of approved treatment options,” said Maria C. Carrillo, Ph.D., chief science officer, Alzheimer’s Association.

“More treatments that target the disease from all angles are needed,” Carrillo added. “We look forward to hearing results from a variety of Alzheimer’s and dementia therapies next week at the Alzheimer’s Association International Conference (AAIC), July 16-20 in Amsterdam.”

The Alzheimer’s Association is committed to working with health systems and providers to ensure they have the resources and infrastructure to meet the needs of their patients. Participation in the Alzheimer’s Association’s Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET), which will gather real world data on how people from all backgrounds and communities respond to novel FDA-approved Alzheimer’s therapies, is encouraged by the FDA in the prescribing information for Leqembi.

With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible. If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis and to discuss treatment options. For more information on diagnosis or to find a local health care provider, visit the Alzheimer’s Association at, or the Helpline 24/7 at 800.272.3900.

About the Alzheimer's Association

The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit or call 800.272.3900.

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