Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the European Commission (EC) has approved Rxulti

大冢制药株式会社（Otsuka）和H. Lundbeck A/S（Lundbeck）今天宣布，欧盟委员会（EC）已批准Rxulti。

(brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.

用于治疗13岁及以上青少年的精神分裂症（brexpiprazole）。

Brexpiprazole was previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.

2018年，Brexpiprazole曾在欧盟获批用于治疗成人精神分裂症。

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.

欧盟委员会基于一项为期6周、随机、双盲、安慰剂对照及活性参照的试验批准了该药物，试验评估了316名青少年患者中药物的有效性和安全性，分别作为主要和次要结果。

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..

Brexpiprazole（2-4毫克/天）在13岁及以上患者中，与安慰剂相比，根据阳性和阴性症状量表（PANSS）总分测量，显示出更大的症状严重程度减轻，并且总体耐受性良好，其安全性与在成年精神分裂症患者中观察到的一致。

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.'.

大冢制药欧洲公司的首席执行官安迪·霍奇表示：“青春期发病的精神分裂症的预后比成人发病的精神分裂症差，并且可能伴随更慢性、更严重的症状。我们欢迎欧盟委员会决定扩大布雷沙匹唑的适应症，以包括13岁及以上的青少年，这为欧洲的年轻人提供了另一种急需的治疗选择。”

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.'.

Lundbeck公司执行副总裁兼研发主管约翰·鲁斯曼表示：“今天标志着年轻患者、护理人员和家庭在应对精神分裂症复杂问题上迈出了重要的一步。此次获批证明了我们致力于减轻欧盟患者和护理人员的疾病负担，并给予他们坚定不移的支持。”

About Rxulti

关于Rxulti

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

布雷克西普拉唑是一种非典型口服抗精神病药，每日服用一次。

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.

布瑞哌唑的药理学被认为是由其在血清素和多巴胺系统中的调节活性所介导的，它结合了在5-HT1A血清素受体和D2多巴胺受体上的部分激动剂活性，以及在5-HT2A血清素受体上的拮抗剂活性，并且对所有这些受体均表现出相似的高亲和力。

Brexpiprazole also shows antagonist activity at noradrenergic α.

布雷克西普拉唑在去甲肾上腺素α受体也显示出拮抗活性。

receptors with affinity in the same sub-nanomolar Ki range.

在相同亚纳摩尔Ki范围内的亲和力受体。

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由大冢制药发现，并根据大冢制药欧洲有限公司与H. Lundbeck A/S之间的合作和许可协议共同开发和共同商业化。

Brexpiprazole was previously approved in the European Union in 2018 for the treatment of adult patients with schizophrenia.

2018年，Brexpiprazole曾在欧盟获批用于治疗成年精神分裂症患者。