FDA Approves Use Of Rexulti By Adolescents Diagnosed With Schizophrenia

The U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for Rexulti (brexpiprazole) for the treatment of schizophrenia in adolescents 13 to 17 years of age. The FDA had initially approved Rexulti in 2015 for treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults. Rexulti is a dopamine D2 and serotonin 5-HT1A partial agonist positioned as a successor to Otsuka’s atypical antipsychotic Abilify (aripiprazole).

Rexulti is manufactured and marketed by Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck). The FDA’s approval was based . . .