FDA approves supplemental new drug application for Rexulti in pediatric patients

The FDA has approved the supplemental new drug application for Rexulti for treating schizophrenia in patients aged 13 to 17 years, Otsuka and Lundbeck announced.

Rexulti (brexpiprazole, Otsuka/Lundbeck) is currently approved in the U.S. as a treatment for adults with schizophrenia and as an adjunctive treatment for adults with major depressive disorder. The companies based the submission on an extrapolation analysis that incorporated data from previous studies in adult patients, pharmacokinetic results from trials in adult and pediatric patients and 6-month data from the ongoing open-label, long-term trial in adolescent patients with schizophrenia.

Interim long-term trial data from 194 adolescent participants, of whom 140 received brexpiprazole for 6 months or longer, were recently presented at Psych Congress, with a manuscript intended for submission to a peer-reviewed scientific journal this year. This age group exhibited generally similar adverse events as those in adult patients. Research has yet to examine the safety and effectiveness of brexpiprazole in pediatric patients with MDD.

“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, chief strategic officer for Otsuka Pharmaceutical Development & Commercialization Inc., said in a press release. “We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options.”