Lundbeck announces FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia
· The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer’s dementia has been accepted and filed by the FDA under Priority review · The FDA target date (PDUFA date) for completion of the review is May 10, 2023 · FDA is currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting · If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer’s dementia in the U.S. Valby, Denmark, January 7, 2023 - H. Lundbeck A/S (Lundbeck) and Otsuka