FDA Approves First-Ever Drug for Agitation Associated with Alzheimer’s Dementia
By Mark Terry
May 11, 2023
The U.S. Food and Drug Administration approved the supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) to treat agitation associated with dementia from Alzheimer’s disease. It is the first and only drug approved for that indication.
Otsuka Pharmaceutical, with U.S. offices in Princeton, N.J., and Danish company Lundbeck co-developed the drug, which was discovered by Otsuka. It was first approved in the U.S. in 2015 as adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) and for schizophrenia in adults.
“Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” said Makoto Inoue, president and representative director of Otsuka, in a press statement. “Otsuka Pharmaceutical will continue its efforts to engage and provide options for those impacted by this devastating condition.”
Agitation is a common neuropsychiatric symptom associated with Alzheimer’s dementia. Often associated with being placed in a nursing home, it is reported in about 50% of Alzheimer’s dementia patients.
In April, a Joint Meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee voted 9-1 to recommend the drug for this indication based on two Phase III, 12-week, randomized, double-blind, placebo-controlled fixed-dose trials. These studies looked at the frequency of agitation symptoms in the patient population based on the Cohen-Mansfield Agitation Inventory (CMAI) total score. The studies’ primary endpoints were change in agitation symptom frequency from baseline at Week 12 in both trials. The studies found that patients receiving the drug had a 31% greater reduction from baseline in frequency of agitation symptoms compared to placebo.
The only abstaining vote was by the consumer representative Kim Witczak. Witczak felt the data did not outweigh the potential risks created by antipsychotic drugs. Brexpiprazole is classified as an atypical antipsychotic. Brexpiprazole brings an increased risk of suicidal thoughts and behaviors in individuals 24 years and younger, which would not generally apply to Alzheimer’s populations.
The drug appeared to be well-tolerated and there was a low incidence of discontinuations. The safety profile was consistent with the drug for other indications.
In a note to investors at the time of the advisory committee meeting, Marc Goodman, analyst with SVB Securities Research, projected the drug could add another $500 million in sales over the next five or six years. In 2022, the drug brought in $572 million for Lundbeck for the MDD and schizophrenia indications.
Deborah Dunsire, CEO and President of Lundbeck, said in a press statement, “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’s disease. 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.”
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Mark Terry is a freelance writer, editor, novelist and ghostwriter. He holds a degree in microbiology & public health and spent 18 years in infectious disease research and clinical and research genetics prior to his transition to a writing career. His areas of expertise include biotechnology, pharma, clinical diagnostics, and medical practice management. He has written literally thousands of articles, as well as market research reports, white papers, more than 20 books, and many other written materials. He currently lives in Michigan with his family.
