FDA approval of sNDA for Rexulti for the treatment of agitation associated with dementia due to Alzheimer’s disease. Lundbeck + Otsuka.

This approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.

Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most complex and stressful aspects of caring for people living with the condition. It is reported in approximately half of people with Alzheimer’s dementia and is associated with earlier nursing home placement. Rexulti is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

The FDA previously granted priority review for the sNDA, a designation for a drug application that represents a significant improvement in the safety and/or effectiveness of the treatment, diagnosis, or prevention of a serious medical condition.

The submission was based on two phase III, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer’s disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score. The primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at Week 12 in both studies. Brexpiprazole patients with agitation associated with dementia due to Alzheimer’s disease achieved a 31% greater reduction from baseline in frequency of agitation symptoms vs. placebo. Overall, the data showed brexpiprazole as being well-tolerated with a low incidence of discontinuations, and with a safety profile consistent with the known safety profile of brexpiprazole in other indications.