BI-Lilly drug is first type 2 diabetes treatment with CV indication

RIDGEFIELD, Conn., and INDIANAPOLIS — Jardiance tablets, marketed by Boehringer Ingelheim and Eli Lilly and Co., have been approved by the Food and Drug Administration to cut the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

BI and Lilly said the FDA clearance makes Jardiance (empagliflozin) the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit.

“As the only diabetes treatment approved by the FDA to reduce the risk of cardiovascular death, Jardiance represents a tremendous step forward in our efforts to reduce the impact of heart disease among adults with type 2 diabetes and cardiovascular disease,” stated Paul Fonteyne, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals Inc. “This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes. We believe that Jardiance is an important treatment option for this patient population.”

In the clinical trial, Jardiance significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo, BI and Lilly reported. Absolute risk reduction was 1.6% for Jardiance versus placebo. That primary finding was driven by a 38% reduction in the risk of cardiovascular death using Jardiance, with absolute risk reduction 2.2% for the medication versus placebo.

There was no change in the risk of non-fatal heart attack or non-fatal stroke in the trial, and the cardiovascular benefits of Jardiance were consistent among patient subgroups.

“Despite significant medical advances, approximately two out of three people with type 2 diabetes still die from cardiovascular disease. The Boehringer Ingelheim and Lilly diabetes alliance is proud to bring a groundbreaking innovation to millions of adults with type 2 diabetes and established cardiovascular disease,” commented Enrique Conterno, senior vice president and president of Lilly Diabetes. “As part of our ongoing commitment to people with type 2 diabetes, we are also expanding our efforts to educate the public on the link between cardiovascular disease and type 2 diabetes.”

Jardiance was approved by the FDA in 2014 as an adjunct to diet and exercise to improve blood glucose levels in adults with type 2 diabetes.

“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for empagliflozin enables physicians for the first time to provide adults with type 2 diabetes with a diabetes medication that can reduce their risk of dying from cardiovascular disease,” added Christopher Cannon, M.D., of the cardiovascular division at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School. “It also gives physicians an opportunity to speak with and educate people with type 2 diabetes about their increased risk for cardiovascular disease and to help them understand this serious complication of their condition.”