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Home » Jardiance CV death risk vote nears for FDA advisors
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Jardiance CV death risk vote nears for FDA advisors

June 27, 2016
By Michael Fitzhugh
FDA reviewers told agency advisors in briefing docs released Friday that Jardiance (empagliflozin) postmarket data show "substantial evidence" that, for certain adults with type 2 diabetes, the drug reduces the risk of cardiovascular death. They did not recommend that the advisors support label claims that the drug could reduce the risk of either hospitalization for heart failure (HF) or a composite of CV death (excluding fatal stroke) or hospitalization for HF.
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