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Home » FDA Extends Diabetic Drug Jardiance’s Label to Include Protection from Cardiovascular Death
FDA Extends Diabetic Drug Jardiance’s Label to Include Protection from Cardiovascular Death
December 9, 2016
The FDA extended the label of Jardiance, originally approved in 2014 to treat Type 2 diabetes, to include the claim that it also reduces the risk of death from heart problems.
The agency’s decision is based on an FDA-required postmarketing study that enrolled more than 7,000 patients with Type 2 diabetes and cardiovascular disease. Jardiance (empagliflozin) was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard therapies.
Jardiance was developed by Boehringer Ingelheim and Eli Lilly & Co. In June, an FDA advisory committee narrowly backed the new indication.
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