Bristol-Myers (BMY) Discontinues Development of Hep C Treatment BMS-986094
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Bristol-Myers Squibb Company (NYSE: BMY) announced that the Company has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C.
This decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that the Company voluntarily suspended on August 1, 2012. The U.S. Food and Drug Administration (FDA) subsequently placed the compound on clinical hold.
The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death. The Company is working in close collaboration with the FDA and clinical study investigators to conduct ongoing, comprehensive assessments and close follow-up of all BMS-986094 study patients. To date, nine patients have been hospitalized, including the initial patient; two patients remain hospitalized. While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interest of patients to halt development of BMS-986094.
This decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that the Company voluntarily suspended on August 1, 2012. The U.S. Food and Drug Administration (FDA) subsequently placed the compound on clinical hold.
The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death. The Company is working in close collaboration with the FDA and clinical study investigators to conduct ongoing, comprehensive assessments and close follow-up of all BMS-986094 study patients. To date, nine patients have been hospitalized, including the initial patient; two patients remain hospitalized. While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interest of patients to halt development of BMS-986094.
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