FDA rules sNDA for treatment of agitation related to dementia sufficient for review

The FDA has determined that the supplementary new drug application for brexpiprazole, a drug to treat agitation associated with Alzheimer’s dementia, is sufficiently complete to permit a substantive review, according to the manufacturers.

The FDA assigned the application priority review and a Prescription Drug User Fee Act target action date of May 10, while indicating it is planning a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application, according to a release issued by Otsuka Pharmaceutical.

“Agitation associated with Alzheimer’s dementia is complex and difficult to navigate for both patients and caregivers,” John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, said in the release. “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.”

The sNDA submission includes data from two positive clinical phase 3 studies that investigated the treatment of brexpiprazole (Rexulti, Otsuka/Lundbeck) in patients with agitation related to Alzheimer’s dementia, per the release.

Study 331-12-283 demonstrated brexpiprazole at 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. In Study 331-14-213, treatment with brexpiprazole at 2 mg/day 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, the companies said in the release.

“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,” Johan Luthman, executive vice president of research and development at Lundbeck, said in the release.