Rxulti®, European

H. Lundbeck A / S England United Kingdom Denmark

07.08.2025 - 18:08:48

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

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
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+45 3630 1311
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Rxulti® approved in the European Union for the treatment of schizophrenia in adolescents

 

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