Jardiance has been given a recommendation from the FDA Advisory Committee. | Courtesy of Morguefile
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Amanda Rupp | Jul 5, 2016

Jardiance receives recommendation from FDA Advisory Committee

Leaders with the U.S. Food and Drug Administration (FDA) Advisory Committee recently recommended Jardiance, which decreases cardiovascular death rates among adults who have type 2 diabetes and cardiovascular disease, for approval with a 12-11 vote.

Jardiance, from Boehringer Ingleheim and Eli Lilly and Company, is the only type 2 diabetes medicine that has been proven to decrease the chances of cardiovascular death in clinical trials.

"Today's robust discussion and resulting vote are important as we look to gain approval of a new indication for Jardiance as the first type 2 diabetes treatment to provide a cardiovascular benefit," Dr. Thomas Seck, vice president of clinical development and medical affairs for Boehringer Ingelheim Pharmaceutical, said. "We look forward to continuing to work with the FDA in our ongoing efforts to provide options that help reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease."

The approval recommendation from the Endocrinologic and Metabolic Drugs Advisory Committee testifies to the mortality benefit of the treatments for adults who have type 2 diabetes.

"Despite significant advances in the prevention and treatment of cardiovascular disease over the past several decades, more than half of adults with type 2 diabetes worldwide still die due to cardiovascular causes," Dr. Jeff Emmick, vice president of product development for Lilly Diabetes, said. "The cardioprotective profile of Jardiance could provide an additional option to physicians to reduce the risk of cardiovascular death in their patients with type 2 diabetes."

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