BMS halts development of Hep C drug after death of patient
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BMS halts development of Hep C drug after death of patient Bristol-Myers Squibb (BMS) has announced that, in the interest of patient safety, it will discontinue the development of BMS-986094, a nucleotide polymerase inhibitor being developed for the treatment of hepatitis C. The company voluntarily suspended a phase II study of BMS-986094 on 1 August 2012 after an initial case of heart failure, which subsequently resulted in death. The US FDA placed the compound on clinical hold. BMS has been working with the FDA and clinical investigators to conduct assessments and closely follow all BMS-986094 study patients. To date, nine patients, including the initial patient, have been hospitalised with unexpected events involving heart and kidney toxicity; two remain hospitalised. The cause of these events has not yet been definitively established. Bristol-Myers Squibb Company. Bristol-Myers Squibb Discontinues Development of BMS-986094, an Investigational NS5B Nucleotide for the Treatment of Hepatitis C. Media Release : 23 Aug 2012. Available from: URL: http:// 809140572 www.bms.com
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Reactions 1 Sep 2012 No. 1417
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