On May 11, 2023, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Otsuka Pharmaceutical and Lundbeck’s Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease.

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. Patients with dementia often have behavioral and psychological disturbances. This was the first FDA-approved treatment option for this indication.