• Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older¹
• Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 2025²
• Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo³

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the European Commission (EC) has approved Rxulti^® (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.¹ Brexpiprazole was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.⁴

The EC based its approval on a 6-week, randomised, 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.³ 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.³

Andy Hodge, CEO at Otsuka Pharmaceutical Europe 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."

Johan Luthman, EVP and Head of Research & Development at Lundbeck 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."

About Rxulti^® (brexpiprazole)

Brexpiprazole is an atypical oral antipsychotic that is taken once a day.⁴ The pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at the serotonin and dopamine systems that combines partial agonist activity at serotonergic 5-HT1A and at dopaminergic D2 receptors with antagonist activity at serotonergic 5-HT2A receptors, with similar high affinities at all of these receptors. Brexpiprazole also shows antagonist activity at noradrenergic α_1B/2C receptors with affinity in the same sub-nanomolar Ki range.^4,5

Brexpiprazole was discovered by Otsuka and is being co-developed and co-commercialised under a collaboration and license agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S.

Brexpiprazole was previously approved in the European Union in 2018 for the treatment of adult patients with schizophrenia.⁴

References

1. European Commission. Rxulti Product Information. Available at: https://ec.europa.eu/health/documents/community-register/html/h1294.htm Accessed: March 2025.
2. Rxulti positive CHMP opinion. Available at: https://www.ema.europa.eu/en/medicines/human/variation/rxulti Accessed: March 2025.
3. Ward C, et al. Oral presentation at the 2024 Annual Congress of the Schizophrenia International Research Society, Florence, Italy.
4. Rxulti SmPC. Available from: https://www.ema.europa.eu/en/documents/product-information/rxulti-epar-product-information_en.pdf Accessed: March 2025.
5. Maeda K, et al. J Pharmacol Exp Ther 2014; 350 (3): 589-604.