European Commission Approves Rxulti for Adolescent Schizophrenia Treatment
In a significant development for adolescent mental health care, Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission (EC) has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.
This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025. The approval is based on a six-week, randomised, double-blind, placebo-controlled, and active-referenced clinical trial involving 316 adolescent patients.
The study evaluated both the efficacy and safety profile of brexpiprazole, demonstrating greater reductions in symptom severity compared with placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score.
The medication, administered at a dosage of 2-4 mg per day, was generally well tolerated, with a safety profile consistent with that observed in adults with schizophrenia.
The CEO of Otsuka Pharmaceutical Europe highlighted the significance of this approval, stating that adolescence-onset schizophrenia often leads to a poorer prognosis compared with adult-onset cases, with more chronic and severe symptoms.
They also expressed optimism about the EC’s decision to extend the indication for brexpiprazole, providing young people in Europe with another much-needed treatment option.
Similarly, the EVP and Head of Research & Development at Lundbeck described the approval as a major milestone for young patients, caregivers, and families navigating the complexities of schizophrenia.
They reiterated the company’s commitment to reducing the disease burden, ensuring that patients and caregivers in the EU have access to a treatment option with proven efficacy and tolerability.
Brexpiprazole is an atypical oral antipsychotic taken once daily, modulating serotonin and dopamine systems to manage schizophrenia symptoms. It was first approved in the European Union in 2018 for the treatment of adult schizophrenia, and this latest approval extends its availability to adolescents aged 13 and older.
To conclude, with schizophrenia often presenting unique challenges in young patients, this regulatory milestone marks a significant step forward in expanding treatment options for adolescents in Europe.
By providing access to an effective and well-tolerated therapy, the approval of brexpiprazole reflects an ongoing commitment to supporting mental health and improving long-term outcomes for young people living with schizophrenia.
News Credits: Rxulti approved in the European Union for adolescent schizophrenia
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