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# Reject Rexulti Alzheimer’s sNDA: Public Citizen
- URL: https://www.fdaweb.com/reject-rexulti-alzheimers-snda-public-citizen/
- Published: 2023-05-04T12:00:00.000Z
- Updated: 2026-09-14T18:29:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154369

Public Citizen says it is strongly urging FDA to reject the sNDA submitted by Otsuka Pharmaceutical Co. and Lundbeck for an expanded indication for Otsuka’s atypical antipsychotic Rexulti (brexpiprazole) to treat agitation associated with Alzheimer’s dementia (AAD). The advocacy group’s 5/3 [letter](https://www.citizen.org/wp-content/uploads/2656.pdf?ref=fdaweb.com) says the drug’s small benefit does not outweigh the significant risks and also says there is no population identified for which the benefits would outweigh the risks.

Public Citizen says it is particularly concerned that these issues, which FDA specifically asked a 4/14 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee to consider, were neither adequately addressed by FDA before or during the meeting nor discussed in depth by the committees. “We believe that the lack of robust discussion of these serious concerns is partially responsible for the almost unanimous agreement (9-1) of the committees on the voting question that the applicant provided sufficient data to allow identification of a population in whom the benefits of treating agitation associated with Alzheimer’s dementia with brexpiprazole outweigh its risks…,” the letter says.

Public Citizen says it disagrees with the agency’s statement that the companies provided substantial evidence of effectiveness. “The benefit was weak,” it says, “and based on three studies of which only two reached statistical significance over placebo for the primary endpoint.”

The letter cautions that if a determination of a specific population for whom the benefit/risk profile is acceptable is not possible based on the available data, “it is reasonable to assume that this drug will be excessively prescribed, often long-term, for most AAD patients, putting them at unnecessary risk with limited or no clinically meaningful benefit.”

“Although we agree that AAD is an unmet need that can be extremely challenging for patients and their caregivers,” Public Citizen concludes, “it seems clear based on the provided data that brexpiprazole does not meet this need…. Patients and caregivers deserve better. They need to be able to trust that a drug approved by FDA for AAD has an acceptable safety profile and has demonstrated consistent, significant, and meaningful benefits. If FDA nevertheless approves brexpiprazole, it will provide false hope to the large number of desperate families of patients with Alzheimer’s dementia.”