FDA accepts brexpiprazole sNDA for priority review in Alzheimer's agitation

The US Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review.

The sNDA was submitted by Denmark’s Lundbeck (LUND: CO) and Japan’s Otsuka Pharmaceutical (TYO: 4578), which co-market the Otsuka discovered drug the oral antipsychotic drug under the Rexulti and Rxulti trade name. The drug generated sales of 2,817 million Danish kroner ($402 million) in the first nine months of 2022.

The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The FDA also indicated that it is currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application.