Brand name : DELTYBA Tablets 50mg
　Active ingredient: Delamanid
　Dosage form: brownish-yellow tablet, diameter: 11.7 mm, thickness: 5.3 mm
　Print on wrapping: Front: デルティバ錠50mg, Otsuka; Back: デルティバ錠50mg, DELTYBA tab 50mg, 吸湿注意, Otsuka
Effects of this medicine
This medicine exerts its antibacterial activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids in M. tuberculosis.
It is usually used to treat pulmonary multidrug-resistant tuberculosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 2 tablets (100 mg of active ingredient) at a time, twice daily after breakfast and dinner. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•As periodic electrocardiographic monitoring and serum albumin concentration measurements are necessary while on this medicine, follow the instructions of your doctor.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include insomnia, headache, and somnolence. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•palpitations, chest discomfort, chest pain [QT prolongation]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•As this medicine is hygroscopic, tablets should be kept in the package sheet and not be removed until immediately before use.
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•If there is a remainder, this is to be discarded. Do not store it. Ask your pharmacist or medical institution about how to discard it.
Otsuka Pharmaceutical Co., Ltd.Internal
Published: 9/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 

 Deltyba™（delamanid）获得欧洲上市许可
•大冢研发的用于治疗耐多药结核病（MDR-TB）新药首次获得上市许可。
•Deltyba成为MDR-TB治疗的一个新选择。据世界卫生组织报告，全球MDR-TB患者的治疗成功率仅为50%，每年17万人死于MDR-TB。
•结核病是大冢研究所于1971年由当时的社长大冢明彦创立时确定的首批研究领域之一。目前，大冢是世界上抗结核药物开发领域的最大出资者。
日本东京--(BUSINESS WIRE)--(美国商业资讯)--大冢制药株式会社（大冢）今天宣布，Deltyba™（delamanid）已获得欧盟委员会的上市批准，在因耐药或耐受性原因而无法组成有效治疗方案的情况下，该药可作为适当联合治疗方案的一部分，用于成人耐多药肺结核病（MDR-TB）患者的治疗。
Deltyba于2008年被认定为孤儿药，这意味着该药是一种用于治疗罕见病的药物。来自9个国家的临床试验结果显示，在接受Deltyba（100毫克，每日2次）联合一个优化的背景方案（OBR）治疗2个月的受试患者中，痰培养转阴（SCC）的比例（45.4%）显著高于接受安慰剂联合一个OBR治疗的患者的SCC比例（29.6%），两者间差异具有统计学意义。SCC是判定患者不再具有传染性的指标。
大冢明彦会长表示：“我很高兴大冢制药开发的新药已经能够在欧洲用于MDR-TB患者的治疗。目前，欧洲的MDR-TB问题很严重。半个世纪前，当利福平问世时，全球的结核病问题似乎就此终结了。然而，我却专门将结核病选定为我们公司的研究课题。我知道必须有人来从事这项研究，因为结核病在亚洲仍是一个重大的公共卫生问题。”
导致对抗结核药产生耐药的原因很多，包括药物使用不当或患者管理不当，例如因潜在药物不良反应而导致患者未完成疗程。MDR-TB的出现已成为全球关注的焦点。由于MDR-TB患者的治疗时间长达至少20个月，这给患者对治疗方案的依从性带来极大困难。从全球来看，仅采用现有抗结核药物治疗MDR-TB患者，其治疗成功率不足50%，这已构成了非常紧迫的未满足的医疗需求。
荷兰格罗宁根大学医学中心的MDR-TB专家Wiel de Lange博士说：“结核病领域对治疗MDR-TB的新药期待已久。随着对现有药物耐药率的不断攀升，全球仅有不足一半的MDR-TB患者得到成功的治疗，Deltyba无疑是一个令人期盼的新选择。”
大冢制药社长岩本太郎评论道：“我非常高兴Deltyba作为一种新型的抗结核药获得欧洲上市许可，这是我们研究所创立以来的一个梦想。全世界仍有众多罹患MDR-TB的患者。我希望Deltyba能够为改善结核病治疗做出贡献。”
为确保患者将来能够持久地受益于Deltyba，大冢已投资制定了负有责任的药物使用计划（Responsible Access Programme ，RAP），以帮助防范对该药可能产生的耐药。RAP包含严格的分销控制、有关Deltyba与其他MDR-TB药物合理配伍使用的专业医学教育，以及一个用于追踪使用Deltyba安全性和有效性的全方位的患者登记管理。大冢坚持致力于为服务需求尚未获满足的群体提供Deltyba，并将在耐多药结核病高负担国家和已开展临床试验的国家申请上市许可。
关于Deltyba
Deltyba适用于成人耐多药肺结核病（MDR-TB）患者，在因耐药或耐受性原因而无法对其组成有效治疗方案的情况下，该药可用作适当联合药物治疗方案的组成部分。成人推荐剂量为100毫克，每日2次，疗程24周。临床试验结果显示，在接受Deltyba（100毫克，每日2次）联合一个OBR治疗2个月的受试患者中，45.4%的患者实现了痰培养转阴（SCC），该指标表明患者不再有传染性；相比之下，在接受安慰剂联合一个OBR治疗的患者中，仅有29.6%的患者实现了SCC，前者比后者高53%，两者间差异有统计学意义。
临床试验结果显示，除QT间期延长以外，Deltyba组的不良事件与安慰剂组接近。心电图显示的QT间期延长在Deltyba（100毫克，每日2次）联合OBR组患者中的发生率为9.9%，而在安慰剂联合OBR组患者中的发生率为3.8%。该不良事件未伴有任何临床症状（例如晕厥或心律不齐）。
关于TB/MDR-TB
据世界卫生组织报告的数据，结核病是传染病中的第二大死因。每年全球的结核病发病人数约为860万，近130万人死于结核病或结核病相关疾病。现有治疗方案要求患者长期服用多种药物，耐药结核病患者的治疗时间长达2年或更长。因抗结核治疗药物使用不当而产生治疗性耐药，包括药物供应不及时、药物质量差或患者无法按治疗方案完成疗程。全世界27个国家承担了90%的MDR-TB负担。