Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
March 13, 2025 – Drug Discovery, Other, Pharmaceutical – European Commission, Lundbeck, Otsuka Pharmaceutical Europe, approvals, schizophrenia
- Brexpiprazole’s indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older
- Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 2025
- Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo.
13 March 2025 — Windsor, UK, and Valby, Denmark — 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. Brexpiprazole was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.
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. 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.
Andy Hodge, CEO at Otsuka Pharmaceutical Europe said, “The prognosis for adolescenceonset 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 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.otsukaeurope.com.
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 programmes 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 neurospecialty 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. Visit: www.lundbeck.com/global.
