FDA Approves Otsuka’s Brexpiprazole As First Therapy For Alzheimer Agitation

The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for Rexulti® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. The sNDA was submitted by Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) under a priority review. The approval makes Rexulti the only pharmacological treatment approved the FDA to treat 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 . . .