Rxulti now approved for adolescents in Europe

The European Commission (EC) has approved Danish CNS specialist Lundbeck (LUND: CO) and Otsuka Pharmaceutical Europe’s Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.

Brexpiprazole, which was discovered by Japan’s Otsuka (TYO: 4578) and licensed to Lundbeck for co-commercialization, was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults. In 2024, Rexulti generated sales of 5,202 million kroner ($754 million), up 16%, for Lundbeck.

The EC decision based its approval on a six-week, randomized, double-blind placebo-controlled and active-referenced trial of 316 adolescent patients, which evaluated the efficacy and safety profile of the drug as primary and secondary outcomes, respectively. Brexpiprazole (2-4mg/day) was associated with greater reductions in symptom severity, as measured by the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo in patients aged 13 years and older, and was generally well tolerated with a safety profile consistent with that seen in adult patients with schizophrenia.