Rxulti approved in the European Union for adolescent schizophrenia

EC extends brexpiprazole indication to include adolescents

Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in January 2025.

The decision was based on a 6-week, randomised, double-blind placebo-controlled and active-referenced trial involving 316 adolescent patients. The study evaluated the efficacy and safety…