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

Rxulti® (brexpiprazole) 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 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

WINDSOR, England and VALBY, Denmark, March 13, 2025 /PRNewswire/ -- Otsuka Pharmaceutical Europe 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 decision 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, by providing a treatment option with proven efficacy and tolerability."

About Rxulti® (brexpiprazole)

Brexpiprazole is an atypical oral antipsychotic that is taken once a day.³ 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

About schizophrenia

Schizophrenia is a chronic, disabling and progressive mental illness, characterised by delusions, hallucinations, and disordered cognition which may occur at varying intervals between periods of relative symptomatic stability.^5,7 Schizophrenia affects approximately 24 million people, or 1 in 300 people (0.32%) worldwide.⁸ Onset is most often during late adolescence and the twenties, and onset tends to happen earlier among men than women.⁸

Schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other important areas of life.⁸ It is one of the top 15 leading causes of disability worldwide.⁹For adolescents with schizophrenia, antipsychotics offer improvements in symptom control; however, younger patients may be particularly vulnerable to side effects.^10,11,12

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide."

Otsuka researches, develops, manufactures, and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programmes in several under-addressed diseases including tuberculosis, a significant global public health issue.

Otsuka Europe employs around 500 people and focuses on psychiatric and neurologic disorders, nephrology and immunology, haemato-oncology, and digital therapeutics. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. 

The Otsuka group of companies employ approximately 35,340 people worldwide with consolidated sales of approximately € 14.1 billion and a spend of € 1.9 billion on research and development in 2024. For further information on Otsuka, please visit www.otsuka-europe.com.

Otsuka contact for media
Alison Ross
Otsuka Pharmaceutical Europe Ltd.
ARoss@Otsuka-Europe.com
+44 776 833 7128

About H. Lundbeck A/S

Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries.

Lundbeck contacts
Investors: 
Jens Høyer
Vice President, Head of Investor Relations,
JSHR@lundbeck.com
+45 30 83 45 01

Media:
Åsa Josefsson
Senior Director, Corporate Communication,
asjs@lundbeck.com
+45 30 83 42 50

References

1. European Commission. Rxulti Product Information. Available at: https://ec.europa.eu/health/documents/community-register/html/h1294.htm Accessed: March 2025. Rxulti positive CHMP opinion. Available at: https://www.ema.europa.eu/en/medicines/human/variation/rxulti Accessed: February 2025.
2. Ward C, et al. Oral presentation at the 2024 Annual Congress of the Schizophrenia International Research Society, Florence, Italy.
3. Rxulti SmPC. Available from: https://www.ema.europa.eu/en/documents/product-information/rxulti-epar-product-information_en.pdf Accessed: February 2025.
4. Maeda K, et al. J Pharmacol Exp Ther 2014; 350 (3): 589–604.
5. Jain R, et al. J Clin Psychiatry 2024; 85 (4): plunaro2417ah.
6. Kahn RS, et al. Nat Rev Dis Primers 2015; 1 (15067). 
7. World Health Organisation. Factsheet, Schizophrenia. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia Accessed: February 2025.
8. Global Burden of Disease Study 2016. Lancet 2017; 390 (10100): 1211–1259.
9. McClellan J & Stock S. J Am Acad Child Adolesc Psychiatry 2013; 52 (9): 976–90.
10. Olfson M, et al. Arch Gen Psychiatry 2012; 69 (12): 1247–56.
11. Pagsberg AK, et al. J Am Acad Child Adolesc Psychiatry 2017; 56 (3): 191–202.

H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
+45 3630 1311
info@lundbeck.com

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