FDA accepts supplemental new drug application for Rexulti
Otsuka and Lundbeck have announced FDA acceptance of a supplemental new drug application for Rexulti for the treatment of schizophrenia in adolescents.
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 application submission occurred 1 year earlier than initially planned.
“There is significant unmet need for treatment options among pediatric schizophrenia patients, so we are pleased to submit this sNDA for Rexulti 1 year ahead of schedule with the hope of eventually serving this important community,” Christoph Koenen, MD, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization Inc., said in a press release.
The accelerated timeline resulted from an extrapolation analysis that used data from prior studies among adult patients, pharmacokinetic results from adult and pediatric trials, and 6-month data from the ongoing open-label, long-term trial among adolescent patients with schizophrenia.
“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, executive vice president of research and development at Lundbeck, said in the release.
Results of an interim analysis of the ongoing trial showed brexpiprazole appeared to be a possible treatment option for adolescent patients with schizophrenia, demonstrating a safety profile consistent with that observed among adult patients. Somnolence was the most common adverse event. Trial results will be presented at the upcoming Psych Congress, which will take place from Oct. 29 to Nov. 1.
According to the release, December is the anticipated month for the FDA to complete its sNDA review.