1xbet 로그인 Pharmaceutical Co., Ltd.
H. Lundbeck A/S

• Brexpiprazole's indication for 1xbet 로그인 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 1xbet 로그인 European Medicines Agency in January 2025²
• Treatment with brexpiprazole (2-4 mg/day) significantly reduced 1xbet 로그인 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 1xbet 로그인 European Commission (EC) has approved Rxulti^®(brexpiprazole) for 1xbet 로그인 treatment of schizophrenia in adolescents aged 13 years and older.¹Brexpiprazole was previously approved in 1xbet 로그인 European Union in 2018 for 1xbet 로그인 treatment of schizophrenia in adults.⁴

1xbet 로그인 EC based its approval on a 6-week, randomised, double-blind placebo-controlled and active-referenced trial of 316 adolescent patients, which evaluated 1xbet 로그인 efficacy and safety profile of 1xbet 로그인 drug as primary and secondary outcomes, respectively.³Brexpiprazole (2-4mg/day) was associated with greater reductions in symptom severity, as measured by 1xbet 로그인 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, "1xbet 로그인 prognosis for adolescence-onset schizophrenia is poor compared with adult-onset schizophrenia and can be associated with more chronic and severe symptoms. We welcome 1xbet 로그인 EC decision to extend 1xbet 로그인 indication for brexpiprazole to include adolescents aged 13 years and older, providing young people in Europe with ano1xbet 로그인r 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 1xbet 로그인 complexities of schizophrenia. This approval is testament to our commitment and unwavering support to lessen 1xbet 로그인 disease burden for patients and caregivers in 1xbet 로그인 EU."

About Rxulti^®(brexpiprazole)

Brexpiprazole is an atypical oral antipsychotic that is taken once a day.⁴ 1xbet 로그인 pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at 1xbet 로그인 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 1xbet 로그인se receptors. Brexpiprazole also shows antagonist activity at noradrenergic α_1B/2Creceptors with affinity in 1xbet 로그인 same sub-nanomolar Ki range.^4,5

Brexpiprazole was discovered by Otsuka 1xbet 로그인 is being co-developed 1xbet 로그인 co-commercialised under a collaboration 1xbet 로그인 license agreement between Otsuka Pharmaceutical Europe Ltd. 1xbet 로그인 H. Lundbeck A/S.

Brexpiprazole was previously approved in 1xbet 로그인 European Union in 2018 for 1xbet 로그인 treatment of adult patients with schizophrenia.⁴

References

1. European Commission. Rxulti Product 1xbet 로그인formation. Available at:https://ec.europa.eu/health/documents/community-register/html/h1294.htmAccessed: March 2025.
2. Rxulti positive CHMP op1xbet 로그인ion. Available at:https://www.ema.europa.eu/en/medic1xbet 로그인es/human/variation/rxultiAccessed: March 2025.
3. Ward C, et al. Oral presentation at 1xbet 로그인 2024 Annual Congress of 1xbet 로그인 Schizophrenia International Research Society, Florence, Italy.
4. Rxulti SmPC. Available from:https://www.ema.europa.eu/en/documents/product-1xbet 로그인formation/rxulti-epar-product-1xbet 로그인formation_en.pdfAccessed: March 2025.
5. Maeda K, et al.J Pharmacol Exp 1xbet 로그인r2014; 350 (3): 589-604.