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FDA approves another indication for Lilly/Boehringer diabetes treatment

Published on 05/12/16 at 11:19am

Jardiance (empagliflozin), an oral SGLT02 inhibitor developed by Eli Lilly and distributed by Boehringer Ingelheim, has been approved by the FDA for an expanded indication, increasing the drug’s applications to include the reduction of risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.

Diabetes patients are at a 70% greater risk of death from cardiovascular disease than those without. Data from a recent 7,000 participant clinical trial showed that as a combination with standard of care treatment, Jardiance succeeded in reducing risk of cardiovascular death, non-fatal heart attack or non-fatal stroke compared to placebo. This data was noted by the FDA as influential on its decision; the association’s advisory committee backed the drug earlier this year in June for its ability to reduce risk of cardiovascular death.

The drug was previously approved in June 2014 for the improvement of glycaemic control in type 2 diabetes sufferers.

“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”

Matt Fellows

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