Otsuka America Pharmaceutical, Inc. and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new
drug application (sNDA) of REXULTI® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. The FDA previously granted Priority Review for the sNDA, a designation for a drug application that, if approved, would represent a significant improvement in the safety and/or effectiveness of
the treatment, diagnosis, or prevention of a serious medical condition. REXULTI was approved in the U.S. in 2015 for the treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults. The submission was based on an extrapolation analysis that used data from prior studies among adult patients,
pharmacokinetic results from adult and pediatric trials, and six-month data from the ongoing open-label, long-term trial among adolescent patients with schizophrenia. The interim data from the long-term trial, comprising data from 194 adolescent patients of which 140 received REXULTI for at least six months, were recently presented at the Psych Congress and a manuscript is planned for submission to a peer-reviewed scientific journal in 2022. Adverse events reported for this age group were generally similar to those observed in adult patients. The safety and effectiveness of REXULTI in pediatric patients with major depressive disorder have not been established.