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Bedaquiline (trade name Sirturo, code names TMC207 and R207910〔) is a medication used to treat tuberculosis. It was discovered by a team led by Koen Andries at Janssen Pharmaceutica. When it was approved by the FDA on the 28th December 2012, it was the first new medicine for TB in more than forty years,〔(【引用サイトリンク】url=http://abcnews.go.com/Health/wireStory/fda-approves-tuberculosis-40-years-18100650#.UOIPT-RQWe0 )〕〔(【引用サイトリンク】url=http://www.nytimes.com/2013/01/01/business/fda-approves-new-tuberculosis-drug.html?_r=0 )〕 and is specifically approved to treat multi-drug-resistant tuberculosis. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. ==Medical uses== Bedaquiline was described for the first time in 2004 at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, after the drug had been in development for over seven years. One of the first published trials of Bedaquiline was a Phase II trial of 47 patients, which showed that the drug was effective in reducing the time to TB-free sputum cultures. A subsequent phase II efficacy trial was published in 2010 and sponsored by Tibotec and the TB Alliance. It is manufactured by Johnson & Johnson (J&J), who sought accelerated approval of the drug, a type of temporary approval for diseases lacking other viable treatment options. By gaining approval for a drug that treats a neglected disease, J&J is now able to request expedited FDA review of a future drug. It was formally approved for use by the U.S. Food and Drug Administration (FDA) for use in tuberculosis (TB) treatment, as part of a fast-track approval for use only in cases of multi-drug-resistant tuberculosis, and the more resistant extensively drug resistant tuberculosis. There is considerable controversy over the approval for the drug, as the FDA's ruling was based on a surrogate outcome (sputum cultures) as opposed to patient deaths. In the clinical trials used for approval, the patients taking bedaquiline were more likely to die (a rate of death of 11.4% in the treatment group, compared to 2.5% in the control group), even though they had resolution of TB based on sputum cultures. For that reason, the label comes with a warning with the heading "WARNINGS: INCREASED MORTALITY; QT PROLONGATION" that says "Only use SIRTURO when an effective treatment regimen cannot otherwise be provided (Indications and Usage (1) and Warnings and Precautions (5.1) )." 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Bedaquiline」の詳細全文を読む スポンサード リンク
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