First novel anti-tuberculosis drug in 40 years

On the last day of 2012, the US Food and Drug Administration (FDA) approved a new drug to treat tuberculosisthe first anti-mycobacterial compound with a novel mechanism of action in 40 years. The agencys go-ahead is for Sirturo (bedaquiline), a diarylquinoline (DARQ) antibiotic, to be dispensed as p...

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Bibliographic Details
Published in:Nature biotechnology 2013-02, Vol.31 (2), p.89-90
Main Author: Osborne, Randy
Format: Article
Language:English
Subjects:
631/154/155
692/308/153
692/699/255/1856
Agriculture
Antitubercular Agents - therapeutic use
Bioinformatics
Biomedical and Life Sciences
Biomedical Engineering/Biotechnology
Biomedicine
Biotechnology
Drug therapy
FDA approval
Humans
Licensing, certification and accreditation
Life Sciences
Mitochondrial Proton-Translocating ATPases - antagonists & inhibitors
Mycobacterium tuberculosis - enzymology
Mycobacterium tuberculosis - pathogenicity
news
Pharmaceutical industry
Product development
Tuberculosis
Tuberculosis - drug therapy
Tuberculosis - epidemiology
Tuberculosis - microbiology
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Summary:On the last day of 2012, the US Food and Drug Administration (FDA) approved a new drug to treat tuberculosisthe first anti-mycobacterial compound with a novel mechanism of action in 40 years. The agencys go-ahead is for Sirturo (bedaquiline), a diarylquinoline (DARQ) antibiotic, to be dispensed as part of combination therapy in cases of multidrug resistance tuberculosis (MDR-TB) when other alternatives are not available. The accelerated approval was based on phase 2 data from 394 patients (a follow-up phase 3 trial is slated for this year). It marks an important breakthrough for the treatment of MDR-TB and is the first of several other compounds with novel mechanisms progressing in the pipeline.
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt0213-89