Otsuka and H. Lundbeck report that the FDA has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole) and 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 U.S. for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults.
The submission has been completed one year earlier than planned, with the hope of benefitting adolescent patients with schizophrenia who need more treatment options.
“There is significant unmet need for treatment options among pediatric schizophrenia patients, so we are pleased to submit this sNDA for Rexulti one year ahead of schedule with the hope of eventually serving this important community,” says Christoph Koenen, M.D., executive vice president, and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc.
The acceleration of the program was made possible by doing an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and 6-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,” says Johan Luthman, executive vice president, Research and Development, Lundbeck.
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