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Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.
The FDA has accepted a supplemental new drug application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti (brexpiprazole). The FDA has granted Otsuka and Lundbeck priority review.
Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the United States for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults.
Rexulti was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.
The submission has been completed one year earlier than planned. This was made possible by doing an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and six-month data from the ongoing open-label, long-term trial in adolescent schizophrenia patients (Trial 331-10-236).
“By using an extrapolation approach in accordance with new regulatory guidance, our goal is to offer a new treatment option to adolescent patients at an accelerated pace compared to previous regulatory guidance,” Johan Luthman, Ph.D., executive vice president, Research and Development, Lundbeck, said in a statement.
Based on an interim analysis of the ongoing long-term trial, Rexulti appears to be a potential treatment option for adolescent patients with schizophrenia, with a safety profile consistent of that observed in adult patients. The most common adverse event was drowsiness with an incidence of 10.2%, and the incidence of restlessness was 2.4%. The results of the more than 100 adolescent patients treated for at least six months from the trial will be presented at the Psych Congress taking place October 29 to November 1, 2021, and will be published in 2022.
The FDA is expected to complete its review of the sNDA by December 2021.