FDA Approves Schizophrenia Drug for Patients Aged 13-17 Years

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.

"This approval further bolsters the mental health community's efforts and resources to address a critical unmet need within the pediatric schizophrenia population," said Robert McQuade, PhD, president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options."

"We are proud to offer a treatment option for adolescents with schizophrenia who are navigating the complexities of their health during a transitional time in their lives – we hope this will help make a meaningful difference in reducing their schizophrenia symptoms so they can be their best," said Johan Luthman, executive vice president, R&D, Lundbeck.