FDA Approves sNDA for Rexulti for Adolescents With Schizophrenia


The agency previously granted a priority review for the supplemental new drug application and also approved the drug in 2015 to treat adults.

The FDA has approved the supplemental new drug application (sNDA) of brexpiprazole (Rexulti, Otsuka) for the treatment of schizophrenia for patients aged 13 to 17 years.1

The FDA has previously granted a priority review for the sNDA, which is a designation for a drug application that, if approved, represents a significant improvement in the effectiveness and/or safety of the diagnosis, prevention, or treatment, of a serious medical condition.1

The agency previously approved Rexulti for the treatment of schizophrenia and adjunctive treatment of major disorder in adults.

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

The submission was based on an extrapolation analysis that used data from prior studies among adult individuals, pharmacokinetic results from adult and pediatric trials, and 6-month data from the ongoing long-term, open-label trial among adolescent individuals with schizophrenia.1

The interim data from the long-term trial, comprising data from 194 adolescent patients, of whom 140 received Rexulti for at least 6 months, were recently presented at the Psych Congress and a manuscript is planned for submission to a peer-reviewed scientific journal in 2022.1

Adverse events (AEs) reported for this age group were generally similar to those observed in adult patients. The effectiveness and safety of Rexulti in pediatric patients with major depressive disorder have not been established.1

The most common adverse reaction observed in adolescents and adults with schizophrenia was weight gain.1

Some adverse events included were neuroleptic malignant syndrome, seizures, stroke, and tardive syskinesia.1

Contradictions include individuals with known hypersensitivity reaction to brexpiprazole or any of its components.1 The reactions include anaphylaxis, facial swelling, rash, and urticaria.

“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,” Johan Luthman, PhD, the executive vice president of R&D at Lundbeck, said in the statement.1

According to the results of a study published in Psychiatriki, childhood schizophrenia is rare before the aged 12 years. However, the incidence rises dramatically in adolescents between aged 13 and 18 years.2

Schizophrenia affects fewer than 1 in every 10,000 individuals before aged 12 years.2


1. Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in pediatric patients ages 13-17. Business Wire. News release. January 6, 2022. Accessed January 7, 2022. https://www.businesswire.com/news/home/20220106005229/en

2. Androutsos C. [Schizophrenia in children and adolescents: relevance and differentiation from adult schizophrenia]. Psychiatriki. 2012;23 Suppl 1:82-93.

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