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Alzheimer's Association Statement on FDA Approval of Brexpiprazole

Alzheimer's Association Statement on FDA Approval of Brexpiprazole
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May 11, 2023
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CHICAGO, May 11, 2023 — On behalf of the millions of Americans impacted by Alzheimer's disease, their families and caregivers, the Alzheimer’s Association welcomes today’s U.S. Food and Drug Administration (FDA) approval of Rexulti® (brexpiprazole) (Otsuka/Lundbeck) for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment to address Alzheimer’s-related agitation.

An estimated 45% of people living with Alzheimer’s disease experience symptoms of agitation, which can include pacing, gesturing, profanity, shouting, shoving and hitting. Agitation symptoms increase the likelihood of residential care placement, decrease patient quality of life and increase caregiver distress. 

“The Alzheimer’s Association is, and has always been, a strong supporter of treatment advancement for all people with Alzheimer’s in all stages of the disease,” said Nicole Purcell, D.O., M.S., Alzheimer’s Association senior director of clinical practice. “People living with moderate and severe Alzheimer’s and other dementia need and deserve treatment that improves the quality of their life, including effective treatments for behavioral and psychiatric symptoms associated with dementia.”

With this approval, the Alzheimer’s Association remains a strong proponent of non-drug approaches for the behavioral symptoms of Alzheimer’s. If the symptoms do not respond to non-drug approaches, particularly for those who have the potential to harm themselves or others, medications may be considered. Those with Alzheimer’s disease experiencing symptoms of agitation should be evaluated by their doctor to determine the most appropriate course of treatment. 

People with Alzheimer's disease experience profound changes in their lives brought on by the disease, which may lead to agitation. Get tips from the Alzheimer's Association on how to recognize and respond to agitation.

We recognize that this treatment to address symptoms will receive coverage from the Centers for Medicare and Medicaid Service (CMS). However, CMS still refuses to cover treatments that address the underlying biology of Alzheimer’s disease. People at all stages of this fatal disease deserve access to treatments.

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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