Rxulti® approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older

H. Lundbeck A/S England United Kingdom Denmark

Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older1Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 20252Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo3Accessed: March 2025. Rxulti positive CHMP opinion. Available at: https://www.ema.europa.eu/en/medicines/human/variation/rxulti Accessed: February 2025.Ward C, et al. Oral presentation at the 2024 Annual Congress of the Schizophrenia International Research Society, Florence, Italy.Rxulti SmPC. Available from: https://www.ema.europa.eu/en/documents/product-information/rxulti-epar-product-information_en.pdf Accessed: February 2025.Maeda K, et al. J Pharmacol Exp Ther 2014; 350 (3): 589–604.Jain R, et al. J Clin Psychiatry 2024; 85 (4): plunaro2417ah.Kahn RS, et al. Nat Rev Dis Primers 2015; 1 (15067). World Health Organisation. Factsheet, Schizophrenia. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia Accessed: February 2025.Global Burden of Disease Study 2016. Lancet 2017; 390 (10100): 1211–1259.McClellan J & Stock S. J Am Acad Child Adolesc Psychiatry 2013; 52 (9): 976–90.Olfson M, et al. Arch Gen Psychiatry 2012; 69 (12): 1247–56.Pagsberg AK, et al. J Am Acad Child Adolesc Psychiatry 2017; 56 (3): 191–202.

H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
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Rxulti® approved in the European Union for the treatment of schizophrenia in adolescents

 

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