Otsuka and Lundbeck Announce FDA Acceptance of Supplemental New Drug Application; Receive Priority Review for Treatment of Schizophrenia in Adolescents

Otsuka和Lundbeck宣布FDA接受补充新药申请;接受青少年精神分裂症治疗的优先审查

2021-10-14 03:30:05 BioSpace

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Submission is based on extrapolation analysis and results examining the effects of Rexulti® 2 to 4 mg/day in treating symptoms of schizophrenia in adolescent patients . Schizophrenia often starts developing during adolescence. PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)-- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole) and has granted Otsuka and Lundbeck Priority Review. Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the U.S. for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211013005651/en/ The submission has been completed one year earlier than planned, with the hope of benefitting adolescent patients with schizophrenia who need more treatment options. “There is significant unmet need for treatment options among pediatric schizophrenia patients, so we are pleased to submit this sNDA for Rexulti one year ahead of schedule with the hope of eventually serving this important community,” says Christoph Koenen, M.D., executive vice president, and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. The acceleration of the program was made possible by doing an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and 6-month data from the ongoing open-label, long-term trial in adolescent schizophrenia patients (Trial 331-10-236). “By using an extrapolation approach in accordance with new regulatory guidance, our goal is to offer a new treatment option to adolescent patients at an accelerated pace compared to previous regulatory guidance,” says Johan Luthman, executive vice president, Research and Development, Lundbeck. Based on an interim analysis of the ongoing open-label, long-term trial, brexpiprazole appears to be a potential treatment option for adolescent patients with schizophrenia, with a safety profile consistent of that observed in adult patients. The most common adverse event was somnolence with an incidence of 10.2%, and the incidence of akathisia was 2.4%. The results of the more than 100 adolescent patients treated for at least 6 months from the trial will be presented at the Psych Congress taking place October 29 to November 1, 2021, and is intended to be published in a peer-reviewed scientific journal during 2022. The FDA is expected to complete its review of the sNDA by December 2021. About the Global Brexpiprazole Pediatric Development Program in Schizophrenia The current global pediatric clinical program includes two completed phase 1 trials and two ongoing phase 3 trials. The two completed phase 1 trials investigated the PK, safety, and tolerability of brexpiprazole. The pharmacokinetic extrapolation was done using data from the two pediatric phase 1 trials together with data from three adult phase 1 trials to build a model that assesses whether the blood concentration of brexpiprazole was similar in adolescents compared to that in adults. Two phase 3 trials are currently underway in adolescents (13-17 years old) with schizophrenia to evaluate short-term efficacy and safety (Trial 331-10-234) and long-term safety and tolerability (Trial 331-10-236) of brexpiprazole as part of the initial agreement on the pediatric program with both FDA and the European Medicines Agency (EMA). About Rexulti/Rxulti (brexpiprazole) Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole is not fully understood. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. Depending on the market, brexpiprazole is known as Rexulti® or Rxulti®. INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole) INDICATIONS REXULTI is indicated for: Use as an adjunctive therapy to antidepressants in adults with major depressive disorder Treatment of schizophrenia in adults IMPORTANT SAFETY INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of REXULTI have not been established in pediatric patients. Contraindication: In patients with known hypersensitivity reaction to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria and anaphylaxis. Cerebrovascular Adverse Events, Including Stroke: In clinical trials, elderly patients with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. REXULTI is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including REXULTI. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of REXULTI, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. For chronic treatment, use the lowest dose and shortest duration of REXULTI needed to produce a clinical response. If signs and symptoms of TD appear, drug discontinuation should be considered. Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including: Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment. Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment. Weight Gain: Weight gain has been observed in patients treated with REXULTI. Monitor weight at baseline and frequently thereafter. Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking REXULTI. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping REXULTI if such urges develop. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia have been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in this class. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue REXULTI at the first sign of a clinically significant decline in WBC and in severely neutropenic patients. Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during initial dose titration and when increasing the dose. Monitor in patients vulnerable to hypotension, and those with cardiovascular and cerebrovascular diseases. Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy. Seizures: REXULTI may cause seizures and should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Body Temperature Dysregulation: Use REXULTI with caution in patients who may experience conditions that increase body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics, including REXULTI, and should be used with caution in patients at risk for aspiration. Potential for Cognitive and Motor Impairment: REXULTI has the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are reasonably certain REXULTI does not affect them adversely. Concomitant Medication: Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers. Most commonly observed adverse reactions: In clinical trials, the most common adverse reactions were: Major Depressive Disorder (MDD) (adjunctive treatment to antidepressant therapy; ≥5% incidence and at least twice the rate of placebo for REXULTI vs. placebo): akathisia and weight increase Schizophrenia (≥4% incidence and at least twice the rate of placebo for REXULTI vs. placebo): weight increased Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses. Pregnancy: Adequate and well-controlled studies to assess the risks of REXULTI during pregnancy have not been conducted. REXULTI should be used during pregnancy only if the benefit justifies the risk to the fetus. Lactation: It is not known if REXULTI is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING. About Schizophrenia in Adolescents Schizophrenia often starts developing during adolescence, with symptoms that tend to be severe. Development of schizophrenia during adolescence is associated with poor long-term outcomes relating to social adjustment, functional impairment, and socioeconomic dependence. Early detection and treatment are currently regarded as the most promising strategies to improve treatment outcomes and long-term prognosis. For adolescents with schizophrenia, antipsychotics offer improvements in symptom control and functioning; however, younger patients may be particularly vulnerable to antipsychotic side effects, highlighting the need for new treatment options. About Lundbeck H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind. Our approximately 5,600 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centers in Denmark and the US and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn. About Otsuka Otsuka Pharmaceutical Co., Ltd. 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, with a focus 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 areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at www.otsuka.co.jp/en/. View source version on businesswire.com: https://www.businesswire.com/news/home/20211013005651/en/ Media Otsuka in U.S. Robert Murphy Corporate Communications Otsuka America Pharmaceutical, Inc. robert.murphy@otsuka-us.com +1 609 249 7262 Otsuka Outside the U.S. Jeffrey Gilbert (Outside the US) Leader, Pharmaceutical PR Otsuka Pharmaceutical, Co., Ltd. gilbert.jeffrey@otsuka.co.jp +81 3 6361 7379 H. Lundbeck A/S Molly Poarch Communications mopc@lundbeck.com +1 224 602 7831 Source: Otsuka Pharmaceutical Co., Ltd. View this news release online at: http://www.businesswire.com/news/home/20211013005651/en
提交的是基于外推分析和结果,检查雷舒利®2至4毫克/天在治疗青少年患者精神分裂症症状方面的效果。精神分裂症通常在青春期开始发展。 新泽西州普林斯顿伊利诺伊州迪尔菲尔德。--(商业快报)--大冢制药有限公司(大冢)和H.Lundbeck a/S(Lundbeck)报告说,美国食品药品监督管理局(FDA)已经接受了一项补充新药申请(sNDA),用于用雷舒替®(布雷克哌唑)治疗青少年精神分裂症,并给予大冢和Lundbeck优先审查。多达三分之一的精神分裂症患者在青春期发病。目前,Rexulti在美国被批准用于治疗成人精神分裂症和成人重度抑郁障碍的辅助治疗。 本新闻稿以多媒体为特色。在这里查看完整版本:https://www.businesswire.com/news/home/20211013005651/en/ 提交工作比计划提前一年完成,希望有利于需要更多治疗选择的青少年精神分裂症患者。 大冢制药开发和商业化公司执行副总裁兼首席医疗官Christoph Koenen医学博士说:“儿科精神分裂症患者对治疗选择的需求有很大的未满足,所以我们很高兴提前一年提交Rexulti的sNDA,希望最终能为这个重要的社区服务。” 通过使用成人患者的先前研究数据、成人和儿科试验的药代动力学结果以及正在进行的青少年精神分裂症患者开放标签长期试验(试验331-10-236)的6个月数据进行外推分析,该方案的加速成为可能。 Lundbeck研发执行副总裁Johan Luthman说:“通过根据新的监管指南使用外推方法,我们的目标是比以前的监管指南更快地为青少年患者提供一种新的治疗选择。” 根据对正在进行的开放标签长期试验的中期分析,布雷克哌唑似乎是青少年精神分裂症患者的潜在治疗选择,其安全性与在成人患者中观察到的一致。最常见的不良事件是嗜睡,发生率为10.2%,静坐不动发生率为2.4%。 从试验开始,对100多名青少年患者进行了至少6个月的治疗,结果将在2021年10月29日至11月1日举行的心理学大会上公布,并计划在2022年期间发表在一份同行评议的科学杂志上。 美国食品和药物管理局预计将在2021年12月前完成对sNDA的审查。 关于全球布雷克哌唑儿童精神分裂症发展计划 目前的全球儿科临床项目包括两个已完成的1期试验和两个正在进行的3期试验。两个完成的1期试验调查了布瑞克哌唑的PK、安全性和耐受性。 药代动力学外推使用来自两个儿童1期试验的数据和来自三个成人1期试验的数据,以建立一个模型来评估青少年与成人相比,英国哌唑的血药浓度是否相似。目前正在青少年(13-17岁)精神分裂症患者中进行两项3期试验,以评估布瑞克哌唑的短期疗效和安全性(试验331-10-234),以及长期安全性和耐受性(试验331-10-236),作为与FDA和欧洲药品管理局(EMA)儿科项目初步协议的一部分。 关于rexulti/rxulti(布雷克哌唑) Brexpiprazole是由Otsuka发现的,由Otsuka和Lundbeck共同开发。目前还不完全清楚布瑞克哌唑的作用机制。然而,英国哌唑的疗效可能是通过5-羟色胺5-HT1A和多巴胺D2受体的部分激动活性和5-羟色胺5-HT2A受体的拮抗活性的组合介导的。Brexpiprazole对这些受体以及去甲肾上腺素α1b/2c受体具有高亲和力(亚纳米摩尔)。根据市场的不同,布雷克哌唑被称为®雷舒尔蒂或®雷舒尔蒂。 雷舒替®的适应症和重要安全性信息 适应症 REXULTI指示用于: 成人重度抑郁障碍患者抗抑郁药的辅助治疗 成人精神分裂症的治疗 重要安全信息 警告:老年痴呆相关精神病患者死亡率增加 老年痴呆相关精神病患者接受抗精神病药物治疗,死亡风险增加。雷舒替未被批准用于痴呆相关精神病患者的治疗。 警告:自杀念头和行为 抗抑郁药增加24岁及更年轻患者自杀想法和行为的风险。监测临床恶化和自杀想法和行为的出现。雷舒替的安全性和有效性尚未在儿科患者中得到证实。 禁忌症:在已知对英国酮哌唑或其任何成分有超敏反应的患者中。反应包括:皮疹、面部肿胀、荨麻疹和过敏反应。 脑血管不良事件,包括卒中:在临床试验中,随机服用利培酮、阿立哌唑和奥氮平的老年痴呆患者卒中和短暂性脑缺血发作的发生率较高,包括致命性卒中。雷舒替未被批准用于痴呆相关精神病患者的治疗。 抗精神病药恶性综合征(NMS):NMS是一种潜在的致命症状复合体,据报道与服用包括雷舒替在内的抗精神病药有关。NMS的临床症状为高热、肌肉僵硬、精神状态改变和自主神经不稳定。其他症状可能包括肌酐磷酸激酶升高、肌红蛋白尿(横纹肌溶解)和急性肾功能衰竭。立即停用雷舒替,加强对症治疗和监测,管理NMS。 迟发性运动障碍(TD):随着治疗时间和抗精神病药物总累积剂量的增加,TD的风险和变得不可逆的可能性被认为是增加的。TD可以在相对较短的治疗期后发展,即使是在低剂量下,或在停止治疗后。对于慢性治疗,使用产生临床反应所需的最低剂量和最短持续时间的雷舒替。如果出现TD的体征和症状,应考虑停药。 代谢改变:非典型抗精神病药物引起的代谢改变包括: 高血糖/糖尿病:在非典型抗精神病药物治疗的患者中,有报道称高血糖,在某些情况下是极端的,与酮症酸中毒或高渗昏迷或死亡有关。评估抗精神病药物开始前或开始后不久的空腹血糖,并在长期治疗期间定期监测。 血脂异常:非典型抗精神病药引起脂质的不良改变。在开始抗精神病药物治疗之前或之后不久,在基线时获得空腹血脂谱,并在治疗期间定期监测。 体重增加:在使用雷舒替治疗的患者中观察到体重增加。在基线时和此后经常监测体重。 病理性赌博和其他强迫行为:强烈的冲动,特别是赌博,并无法控制这些冲动已被报告在服用雷舒利。其他强迫性冲动的报告频率较低。处方者应该询问病人或他们的照顾者关于新的或强烈的强迫性冲动的发展。如果这种冲动发展,考虑减少剂量或停止雷舒替。 白细胞减少、中性粒细胞减少和粒细胞缺乏:白细胞减少和中性粒细胞减少已报告抗精神病药物。粒细胞缺乏症(包括致命病例)已报告与其他代理人在这类。监测先前存在低白细胞计数(WBC)/中性粒细胞绝对计数或药物诱导白细胞减少/中性粒细胞减少病史的患者的完全血细胞计数。在白细胞和严重中性粒细胞减少的患者出现临床显著下降的第一个迹象时,停止使用雷舒利。 直立性低血压和晕厥:非典型抗精神病药引起直立性低血压和晕厥。通常,在初始剂量滴定和增加剂量时风险最大。监测对象为低血压患者和心脑血管疾病患者。 跌倒:抗精神病药物可能导致嗜睡、体位性低血压、运动和感觉不稳定,这可能导致跌倒造成骨折或其他损伤。对于有可能加重这些影响的疾病、条件或药物的患者,在开始治疗时和治疗期间反复进行跌倒风险评估。 癫痫发作:雷舒替可能引起癫痫发作,对于有癫痫发作史或癫痫发作阈值较低的患者应谨慎使用。 体温调节障碍:对于可能出现体温升高(如剧烈运动、酷热、脱水或同时使用抗胆碱药)的患者,慎用雷舒利。 吞咽困难:食道运动障碍和误吸与抗精神病药物有关,包括雷舒替,在有误吸风险的患者中应谨慎使用。 潜在的认知和运动障碍:雷舒利有潜在的损害判断,思考,或运动技能。病人不应该驾驶或操作危险的机器,直到他们合理地确定雷舒利不会对他们产生不利影响。 同时用药:已知细胞色素P450(CYP)2D6代谢不良的患者,以及同时服用CYP3A4抑制剂或CYP2D6抑制剂或强CYP3A4诱导剂的患者,建议调整剂量。 最常见的不良反应:在临床试验中,最常见的不良反应是: 重性抑郁障碍(MDD)(抗抑郁治疗的辅助治疗;发生率≥5%,且雷舒替安慰剂与安慰剂相比至少是安慰剂的两倍):静坐不动和体重增加 精神分裂症(≥4%的发病率和至少两倍于安慰剂的雷舒替安慰剂的比率):体重增加 肌张力障碍:在治疗的第一天和低剂量下,易感个体可能会出现肌张力障碍的症状。 怀孕:尚未进行充分和良好控制的研究来评估怀孕期间雷舒替的风险。只有在好处证明对胎儿有风险的情况下,才应该在怀孕期间使用雷舒替。 泌乳:尚不知道雷舒替是否在人类母乳中排泄。应考虑到药物对母亲的重要性,决定是停止哺乳还是停止用药。 要报告可疑的不良反应,请联系大冢美国制药公司,电话1-800-438-9927或FDA电话1-800-FDA-1088(www.FDA.gov/medwatch)。 请查看完整的处方信息,包括装箱警告。 关于青少年精神分裂症 精神分裂症通常在青春期开始发展,症状往往很严重。青春期精神分裂症的发展与社会适应、功能障碍和社会经济依赖方面的长期不良结果有关。早期发现和治疗是目前最有希望改善治疗结果和长期预后的策略。对于患有精神分裂症的青少年,抗精神病药物可以改善症状控制和功能;然而,年轻患者可能特别容易受到抗精神病药物副作用的影响,这突出表明需要新的治疗选择。 关于Lundbeck H.Lundbeck a/S(LUN.co,LUN DC,HLUYY)是一家专门从事脑部疾病的全球性制药公司。70多年来,我们一直走在神经科学研究的前沿。我们孜孜不倦地致力于恢复大脑健康,这样每个人都可以做到最好。 全世界有数百万人患有脑部疾病,由于治疗不足、歧视、工作日减少、提前退休和其他不必要的后果,有太多的人患有脑部疾病。每一天,我们都在为脑部疾病患者争取更好的治疗和更好的生活--我们把这种进步称为铭记于心。 我们在50多个国家的约5600名员工从事研究、开发、生产、营销和销售的整个价值链。我们的管道包括几个研发项目,我们的产品可在100多个国家。我们在丹麦和美国都有研究中心,我们的生产设施位于丹麦、法国和意大利。Lundbeck在2020年创造了177亿丹麦克朗的收入(24亿欧元;27亿美元)。 欲了解更多信息,我们鼓励您访问我们的企业网站www.lundbeck.com,并通过Twitter@lundbeck和LinkedIn与我们联系。 关于大冢 大冢制药株式会社是一家全球性的医疗保健公司,其企业理念是:“大冢--为全世界更好的健康创造新产品。”大冢研究、开发、制造和营销创新产品,专注于满足未满足的医疗需求的制药产品和维护日常健康的营养产品。 在制药方面,大冢是精神、肾脏和心血管健康等具有挑战性领域的领导者,并在肿瘤学和包括结核病在内的几种未得到解决的疾病方面拥有额外的研究项目,结核病是一个重要的全球公共卫生问题。这些承诺说明了大冢公司本质上是一家“大冒险”公司,在它所做的每一件事上都应用着年轻的创造力。 大冢于1973年在美国建立了业务,今天它在美国的子公司包括大冢制药开发和商业化公司(OPDC)和大冢美国制药公司(OAPI)。这两家公司在美国的1700名员工使用尖端技术开发和商业化精神健康、肾病学和心脏病学领域的药物,以满足未满足的医疗保健需求。 OPDC和OAPI是大冢制药株式会社的间接子公司,大冢制药株式会社是总部位于日本东京的大冢控股株式会社的子公司。大冢公司集团在全球雇佣了47,000名员工,2020年的综合销售额约为133亿美元。 所有的大冢故事都是从走较少人走过的路开始的。了解更多关于美国大冢的信息,请访问www.otsuka-us.com,并在领英和推特@otsukaus与我们联系。大冢制药公司的全球网站可访问www.Otsuka.co.jp/en/。 在businesswire.com查看源代码版本:https://www.businesswire.com/news/home/20211013005651/en/ 媒体 美国大冢。 罗伯特·墨菲 企业传播 大冢美国制药公司。 @otsuka-us.com +1 609 249 726 2 美国以外的大冢 杰弗里·吉尔伯特(《美国外》) 制药公关负责人 大冢制药,株式会社。 @otsuka.co.jp +81 3 636 1 737 9 H.Lundbeck A/S 莫利·波阿奇 通信 @lundbeck.com +1 224 602 783 1 资料来源:大冢制药株式会社 在网上查看此新闻稿: http://www.businesswire.com/news/home/20211013005651/en

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