The US 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 per cent 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).

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes (T2D) at high risk for cardiovascular (CV) events.

The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 per cent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. Treatment with Jardiance also resulted in a 32 per cent reduction in all-cause mortality and a 35 per cent reduction in hospitalization for heart failure. The overall safety profile of Jardiance was consistent with that of previous trials.

Jardiance is a prescription medicine used along with diet and exercise to lower blood sugar 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).

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation.