Otsuka Pharmaceutical and H. Lundbeck have received approval from the European Commission for Rxulti (brexpiprazole) to treat schizophrenia in adolescents aged 13 years and older.
The latest development follows the drug’s earlier authorisation for adult schizophrenia in the European Union, which was granted in 2018.
The approval from the EC is based on findings from a clinical trial involving 316 adolescent participants. This six-week study was designed as a randomised, double-blind, placebo-controlled trial that assessed both the efficacy and safety of brexpiprazole, focusing on primary and secondary outcomes.
The decision comes after a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which was issued in January 2025.
In the trial, brexpiprazole, administered at daily doses ranging from 2 to 4 mg, showed significant improvements in symptom severity, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, compared to the placebo group.
The safety profile of the drug was found to be consistent with that observed in adult patients with schizophrenia.
Brexpiprazole is classified as an atypical oral antipsychotic that is taken once daily. Its pharmacological mechanism is believed to involve a modulatory effect on both serotonin and dopamine systems. This includes partial agonist activity at the serotonergic 5-HT1A and dopaminergic D2 receptors, alongside antagonist activity at the serotonergic 5-HT2A receptors.
Additionally, brexpiprazole exhibits antagonist properties at noradrenergic α1B/2C receptors, with a high affinity in the sub-nanomolar Ki range.
Otsuka Pharmaceutical Europe CEO Andy Hodge said: “The prognosis for adolescence-onset schizophrenia is poor compared with adult-onset schizophrenia and can be associated with more chronic and severe symptoms.
“We welcome the EC decision to extend the indication for brexpiprazole to include adolescents aged 13 years and older, providing young people in Europe with another much-needed treatment option.”
Lundbeck EVP, R&D head Johan Luthman said: “Today marks a major milestone for young patients, caregivers, and families navigating the complexities of schizophrenia. This approval is testament to our commitment and unwavering support to lessen the disease burden for patients and caregivers in the EU.”
