FDA Panel Votes in Favor of Brexpiprazole as Potential Therapy for Alzheimer Agitation

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted that the current data on brexpiprazole, an agent under review for Alzheimer disease (AD) agitation, have shown enough evidence of benefit to outweigh its potential risks. The agent currently has a PDUFA date of May 10, 2023, and, if approved, would be the first agent specifically to treat AD agitation.

The committee was asked to vote on whether the provided data was sufficient to allow the identification of a population in whom the benefits of treating agitation associated with Alzheimer dementia with brexpiprazole outweighed its risks. At the end of the hearing, the committee voted 9–1 (9 yes; 1 no; 0 abstain) in favor of the agent.