Otsuka Pharmaceutical Co., Ltd.

January 7, 2022

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-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A 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.