FDA Approves First Treatment for Agitation Associated With Alzheimer Disease Dementia

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Brexpiprazole (Rexulti) has been approved by the US Food and Drug Administration for the treatment of agitation associated with Alzheimer disease dementia (AAD). It is now the first FDA-approved treatment indicated for AAD in the United States.¹

“The FDA has approved the first ever drug to treat AAD, one of the largest unmet needs in medicine and neuropsychiatry in the context of a rapidly ageing population,” said John J. Miller, MD, Editor in Chief of Psychiatric Times. “Baby boomers are retiring and Alzheimer disease is on the rise, and AAD in one of the most difficult complications of dementia. Meanwhile, the need for treatments of Alzheimer disease and dementia remains huge and largely unaddressed. This approval parallels nicely with recent drug development and research working on decreasing disease progression by removing amyloid plaque with monoclonal antibodies and improving cognitive function.”

In July 2015, the FDA approved as a treatment both for adults with schizophrenia and as an add-on treatment for adults with major depressive disorder.² Data from two phase 3 studies showed that brexpiprazole 2 mg or 3 mg doses significantly (p<0.05) improved symptoms of agitation in patients with AAD compared with placebo.³ It is worth noting, however, that brexpiprazole’s label features a black box warning for increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs.⁴

“This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer disease," said Deborah Dunsire, CEO and president of Lundbeck. "We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials."¹

References

1. Otsuka and Lundbeck announce U.S. Food and Drug Administration (FDA) approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease. Otsuka. News release. May 11, 2023. https://otsuka-us.com/news/otsuka-and-lundbeck-announce-us-food-and-drug-administration-fda-approval-supplemental-new

2. Kuntz L. “A viable option” for treating schizophrenia receives FDA approval. Psychiatric Times. January 6, 2022. https://www.psychiatrictimes.com/view/a-viable-option-for-treating-schizophrenia-receives-fda-approval

3. Otsuka Pharmaceutical and Lundbeck present positive data from multiple phase 3 studies showing brexpiprazole significantly improved symptoms of agitation in patients with Alzheimer's dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress. Otsuka. News release. December 1, 2022. Accessed May 10, 2023. https://www.otsuka-us.com/news/otsuka-pharmaceutical-and-lundbeck-present-positive-data-multiple-phase-3-studies-showing

4. Zamecnik A. FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD. Pharmaceutical Technology. April 17, 2023. Accessed May 10, 2023. https://www.pharmaceutical-technology.com/news/fda-adcom-votes-in-favour-of-lundbecks-otsukas-rexulti-in-aad