U.S. FDA Accepts Filing of Cardiovascular Outcomes Data for Jardiance® (empagliflozin)

RIDGEFIELD, Conn. and INDIANAPOLIS, The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application for Jardiance® (empagliflozin) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME® trial. Boehringer Ingelheim and Eli Lilly and Company expect to receive a decision from the FDA within the standard review time frame.

Cardiovascular complications can have a significant impact on the health and life expectancy of people with type 2 diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.

"We're proud of this acceptance as we are now one step closer to helping address one of the most prevalent clinical needs of the type 2 diabetes community — reducing the risk of cardiovascular death," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to working with the FDA as it reviews the data from the EMPA-REG OUTCOME trial."

JARDIANCE was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Source: Eli Lilly and Company; Boehringer Ingelheim