Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI (brexpiprazole) to Treat Schizophrenia in Pediatric Patients®

Otsuka Pharmaceutical Co., Ltd. (Otsuka); its subsidiary Otsuka America Pharmaceutical, Inc.; and Lundbeck, Inc., a U.S. subsidiary of H. Lundbeck A/S in Denmark, announce that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age.® The FDA previously granted Priority Review for the sNDA, a designation for a drug application that, if approved, would represent a significant improvement in the safety and/or effectiveness of the treatment, diagnosis, or prevention of a serious medical condition. REXULTI was approved in the U.S. in 2015 for the treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults. About Rexulti/Rxulti (brexpiprazole) Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole is not fully understood. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT and dopamine D receptors, and antagonist activity at serotonin 5-HT receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. Depending on the market, brexpiprazole's brand name is Rexulti or Rxulti.1A22A

The release as fetched from its publisher. otsuka.co.jp ↗