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。3 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）。
Deltyba 50 mg Filmtabletten - OP300; Filmtablette; Otsuka Novel Products GmbH
Allgemeine Angaben
Eingangsnummer : 2710006
Arzneimittelname: Deltyba 50 mg Filmtabletten - OP300
Darreichungsform : Filmtablette
Administrative Daten
Antragsteller: Otsuka Novel Products GmbH
Verkehrsfähig : ja
Zulassungs-/Reg-Nr.(AMG76) : EU/1/13/875/003
Zusammensetzung
Arzneilich wirksame Bestandteile
ASK-Nr. Stoffname Stoffmenge
Delamanid 50.mg
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002552/WC500155458.pdf
Information
Generic Name: delamanid
Trade Name: Deltyba
Entry Type: New molecular entity
Developmental Status
UK: Launched
EU: Launched
US: Phase II Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date: 01/05/2014
Comments
May 14: Launched in the UK 30th May [10,11].
11/06/2014 10:25:47
Apr 14: Approved in the EU for use as part of an appropriate combination regimen for MDR-TB in adults when other therapies are resisted or cannot be tolerated [9].
01/05/2014 12:21:46
Nov 13: EU positive opinion. The CHMP recommends granting a conditional marketing authorisation for Deltyba 50 mg film-coated tablet for treatment of pulmonary multi-drug resistant tubercolosis (MDR-TB) in adults when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability [8].
22/11/2013 14:35:42
Jul 13: EU negative opinion. The CHMP considered that the benefits of delamanid in the treatment of multi-drug resistant TB had not been sufficiently shown; duration of treatment in the main study (two months) was too short & could not be used to predict the effectiveness when delamanid was given for six months, extension and follow-up studies included only pts who had agreed to take part and might not be representative of pts as a whole, and it was not possible to determine the most appropriate dosing for delamanid [7].
26/07/2013 14:19:14
Dec 11: Filed in the EU [3,4].
14/08/2012 10:59:44
Trial or other data
Oct 12: Open label extension of a PIIb (n=481) study published early online in Eur Resp J. Overall, favourable outcomes were significantly increased in pts in the long-term (≥6 months) treatment group at 74.5% (95% CI 67.7-80.5), vs. 55.0% (48.3-61.6) among those in the short-term (≤2 months) treatment group who were treated with delamanid or placeb
