Lundbeck and Otsuka announce U.S. Food and Drug Administration (FDA) approval of sNDA for Rexulti® (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s Disease
· Rexulti is the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease Valby, Denmark, May 11, 2023 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Rexulti® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. This approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for agitation