References
- World Health OrganizationGlobal tuberculosis report 2014GenevaWorld Health Organization2014 Available from: http://www.who.int/tb/publications/global_report/en/Accessed September 27, 2015
- ZumlaAChakayaJCentisRTuberculosis treatment and management – an update on treatment regimens, trials, new drugs, and adjunct therapiesLancet Respir Med20153322023425773212
- MaZLienhardtCMcIlleronHNunnAJWangXGlobal tuberculosis drug development pipeline: the need and the realityLancet201037597312100210920488518
- MatsumotoMHashizumeHTomishigeTOPC-67683, a nitrodihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in micePLoS Med2006311e46617132069
- World Health OrganizationThe Selection and Use of Essential Medicine Report: 20–24 April, 2015GenevaWorld Health Organization Available from: http://www.who.int/medicines/publications/essential-medicines/Executive-Summary_EML-2015_7-May-15.pdfAccessed June 6, 2015
- World Health OrganizationThe Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis Interim Policy Guidance 2014GenevaWorld Health Organization Available from: http://apps.who.int/iris/bitstream/10665/137334/1/WHO_HTM_TB_2014.23_eng.pdf?ua=1Accessed September 27, 2015
- World Health Organization. [homepage on the Internet]An initiative to extend access to a new TB drug2015World Health Organization Available from: http://www.who.int/tb/features_archive/otsuka_2015/en/Accessed September 27, 2015
- UNITAID [homepage on the Internet]UNITAID joins health partners to launch new treatment for drug-resistant TB2015UNITAID Available from: http://www.unitaid.eu/en/resources/press-centre/20-news/statements/1433-unitaid-joins-health-partners-to-launch-new-treatment-for-drug-resistant-tbAccessed September 27, 2015
- AhujaSDAshkinDAvendanoMMultidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patientsPLoS Med201298e100130022952439
- World Health OrganizationGuidelines for Medicine Donations Revised 2010GenevaWorld Health Organization Available from: http://www.who.int/medicines/publications/med_donationsguide2011/en/Accessed September 27, 2015
- GuillouxAMoonSHidden Price Tags: Disease-Specific Drug Donations: Costs and AlternativesAccess to Essential Medicines Campaign, Médecins Sans FrontièresGeneva, Switzerland2014 Available from: http://www.researchgate.net/publication/242325532_Hidden_Price_Tags_Disease-Specific_Drug_Donations_Costs_and_AlternativesAccessed September 27, 2015
- Treatment Action Group [homepage on the Internet]Treatment Action Group Applauds European Approval of New Drug to Fight Tuberculosis, Demands Expanded Access and Affordable PricingTreatment Action Group2013 Available from: http://www.treatmentactiongroup.org/tb/press/2013/tag-applauds-european-approval-new-drug-fight-tuberculosis-demandsAccessed September 27, 2015
- World Health OrganizationInterim Policy Guidance for the Use of Bedaquiline in the Treatment of MDR-TBGenevaWorld Health Organization2013 Available from: http://www.who.int/tb/challenges/mdr/bedaquiline/en/Accessed September 27, 2015
- Otsuka Pharmaceutical Development and Commercialization, IncSafety and Efficacy Trial of Delamanid for 6 Months in Patients With Multi-drug Resistant Tuberculosis Available from: https://clinicaltrials.gov/ct2/show/NCT1424670?term=phase+III+trial+delamanid&rank=1. NLM identifier: NCT1424670Accessed September 27, 2015
- European Medicines AgencyEuropean Public Assessment Report: Del-tyba (delamanid)2014428 Available at: thttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002552/WC500166234.pdfAccessed September 27, 2015
- European Medicines AgencyDeltyba (delamanid): Authorization DetailsEuropean Medicines Agency2014 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002552/human_med_001699.jsp&mid=WC0b01ac058001d124Accessed September 27, 2015
- Otsuka Pharmaceutical Co., LtdAfter 40 years, a new drug for the treatment of tuberculosis in Japan [press release]JapanOtsuka Pharmaceutical Co, Ltd201474 Available from: http://www.otsuka.co.jp/en/company/release/2014/0704_02.htmlAccessed September 27, 2015
- Otsuka Pharmaceutical Development and Commercialization, IncPharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis Available from: https://clinicaltrials.gov/ct2/show/NCT1856634?term=delamanid+pediatric&rank=2. NLM identifier: NCT1856634Accessed September 27, 2015
- Otsuka Pharmaceutical Development and Commercialization, IncA 6-Month Safety, Efficacy, and Pharmacokinetic Trial of Delamanid in Pediatric Patients With Multidrug Resistant Tuberculosis Available from: http://clinicaltrials.gov/ct2/show/NCT1859923?term=delamanid&rank=1. NLM identifier: NCT1859923Accessed September 27, 2015
- European Medicines AgencySummary of Opinion Initial AuthorizationDeltyba (delamanid) Committee for Medicinal Products for Human Use (CHMP)2013 EMA/CHMP/713909/2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002552/WC500155458.pdfAccessed September 27, 2015
- NHS England Specialised Services Clinical Reference Groups for Infectious Diseases and Respiratory MedicineClinical Commissioning Policy: Bedaquiline and Delamanid for Defined Patients with MDR-XDR-TBNHSEngland2014 Available from: https://www.engage.england.nhs.uk/consultation/specialised-services-consultation/user_uploads/bedaquiline-delamanid-policy-upd.pdfAccessed September 27, 2015
- European Medicines AgencySummary of product characteristicsDeltyba. Otsuka Novel Products GmbH. European Medicines Agency2014 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002552/WC500166232.pdfAccessed September 27, 2015
- PaccalyAPetersenCPatilSAbsence of clinically relevant drug interaction between delamanid, a new drug for multidrug-resistant tuberculosis (MDR-TB) and tenofovir or lopinavir/ritonavir in healthy subjectsPoster presented at: 19th International AIDS ConferenceJuly 22–27; 2012Washington, DC
- PetersenCDelamanid, a new drug for multi-drug resistant tuberculosis (MDR-TB), and efavirenz do not show clinically relevant drug interactions in healthy subjects Poster abstract A-1255Presented at: 52nd Interscience Conference on Antimicrobial Agents and ChemotherapySeptember 9–12; 2012San Francisco, CA
- DiaconAHDawsonRHanekomMEarly bactericidal activity of delamanid (OPC-67683) in smear-positive pulmonary tuberculosis patientsInt J Tuberc Lung Dis201115794995421682970
- GlerMTSkripconokaVSanchez-GaravitoEDelamanid for multidrug-resistant pulmonary tuberculosisN Engl J Med2012366232151216022670901
- ZhangQLiuYTangSShaWXiaoHClinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in ChinaCell Biochem Biophys201367395796323546935
- SkripconokaVDanilovitsMPehmeLDelamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosisEur Respir J20134161393140023018916
- LewisJMSloanDJThe role of delamanid in the treatment of drug-resistant tuberculosisTher Clin Risk Manag20151177979125999726
- GuptaRGeiterLJWellsCDGaoMCiruleAXiaoHDelamanid for Extensively Drug-Resistant TuberculosisN Engl J Med2015373329129226176402
- RESIST-TB [homepage on the Internet]DR-TB Clinical Trial Progress Report. A Trial of the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid Available from: http://www.resisttb.org/?page_id=1602Accessed September 27, 2015
- EspositoSD’AmbrosioLTadoliniMERS/WHO Tuberculosis Consilium assistance with extensively drug-resistant tuberculosis management in a child: case study of compassionate delamanid useEur Respir J201444381181524833763
- NachmanSAhmedAAmanullahFTowards early inclusion of children in tuberculosis drugs trials: a consensus statementLancet Infect Dis201515671172025957923
- No authors listedAccess to medicines is a global struggleThe Pharmaceutical Journal20142937830