Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer's dementia (AAD) is sufficiently complete to permit a substantive review.

The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The FDA also indicated that they are currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application.

The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213, treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).

"Agitation associated with Alzheimer's dementia is complex and difficult to navigate for both patients and caregivers," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "New treatments in this area are desperately needed. Our commitment to patients is unwavering as we work to provide them and their caregivers with an option to help lessen the symptoms of agitation."

"This milestone is important in our efforts to bring patients with Alzheimer's dementia and their caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of the disease," said Johan Luthman, executive vice president, Lundbeck Research & Development.