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Merck & Co Inc announces US FDA approved ZONTIVITY

Monday, 12 May 2014 07:30am EDT 

Merck & Co Inc:US FDA approved ZONTIVITY (vorapaxar) for reduction of thrombotic cardiovascular events in patients with history of heart attack or in patients with narrowing of leg arteries, called peripheral arterial disease.ZONTIVITY added to standard of care produced significant 17 pct relative risk reduction over three years of study for combined events of cardiovascular (CV) death, myocardial infarction (MI), stroke, and urgent coronary revascularization.For key secondary composite efficacy endpoint of CV death, MI and stroke alone, ZONTIVITY produced significant 20 pct relative risk reduction in these patients.These results were driven by an 18 pct relative risk reduction in MI and 33 pct relative risk reduction in first stroke.Prescribing information for ZONTIVITY includes boxed warning regarding bleeding risk.ZONTIVITY is not for use in patients with a history of stroke, TIA or intracranial hemorrhage, or active pathological bleeding. 

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