Delamanid: First Global Approval

被引：155

作者：

Ryan, Nicola J. ^{[1
]}

Lo, Jin Han ^{[2
]}

机构：

[1] Adis, Auckland, New Zealand

[2] Adis, Northcote 0627, New Zealand

来源：

DRUGS | 2014年 / 74卷 / 09期

关键词：

MULTIDRUG-RESISTANT TUBERCULOSIS; PULMONARY TUBERCULOSIS; BACTERICIDAL ACTIVITY; OPC-67683;

D O I：

10.1007/s40265-014-0241-5

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. It is also under review for marketing in Japan for MDR-TB, the first drug application filed in Japan for this indication. Delamanid has been granted orphan drug status in both the EU and Japan. This article summarizes the milestones in the development of delamanid leading to this first approval for MDR-TB.

引用

页码：1041 / 1045

页数：5

共 14 条

[1] Early bactericidal activity of delamanid (OPC-67683) in smear-positive pulmonary tuberculosis patients [J].

Diacon, A. H. ;

Dawson, R. ;

Hanekom, M. ;

Narunsky, K. ;

Venter, A. ;

Hittel, N. ;

Geiter, L. J. ;

Wells, C. D. ;

Paccaly, A. J. ;

Donald, P. R. .

INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE, 2011, 15 (07) :949-954

[2] New treatment options for multidrug-resistant tuberculosis [J].

Field, Stephen K. ;

Fisher, Dina ;

Jarand, Julie M. ;

Cowie, Robert L. .

THERAPEUTIC ADVANCES IN RESPIRATORY DISEASE, 2012, 6 (05) :255-268

[3] Drugs in Development for Tuberculosis [J].

Ginsberg, Ann M. .

DRUGS, 2010, 70 (17) :2201-2214

[4]

Gler MT, 2012, NEW ENGL J MED, V366, P2151, DOI 10.1056/NEJMoa1112433

[5] OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice [J].

Matsumoto, Makoto ;

Hashizume, Hiroyuki ;

Tomishige, Tatsuo ;

Kawasaki, Masanori ;

Tsubouchi, Hidetsugu ;

Sasaki, Hirofumi ;

Shimokawa, Yoshihiko ;

Komatsu, Makoto .

PLOS MEDICINE, 2006, 3 (11) :2131-2144

[6]

Otsuka Pharmaceutical, PHARM SAF TRIAL DET

[7]

Otsuka Pharmaceutical, 6 MONTH SAF EFF PHAR

[8]

Otsuka Pharmaceutical, SAF EFF DEL 6 MONTHS

[9]

Otsuka Pharmaceutical, SUMM PROD CHAR

[10] Bactericidal activity of OPC-67683 against drug-tolerant Mycobacterium tuberculosis [J].

Saliu, Oluwabunmi Y. ;

Crismale, Catina ;

Schwander, Stephan K. ;

Wallis, Robert S. .

JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2007, 60 (05) :994-998

← 1 2 →