Otsuka Pharmaceutical Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced on Thursday that the United States Food and Drug Administration (FDA) approved supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for treatment of "agitation" associated with dementia caused by Alzheimer's disease.
The drug represents the "first" and "only" licensed treatment for the aforementioned disease in the United States.
"We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials," Lundbeck CEO Deborah Dunsire said.