Positive FDA AdCom on brexpiprazole for Alzheimer's agitation

The Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration’s (FDA) on Friday discussed supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD).

Rexulti is being developed by discoverer Japan’s Otsuka (TYO: 4578) and Denmark’s Lundbeck (LUND: CO).

The committee voted 9-1 that the companies provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with brexpiprazole outweigh its risks.