OREANDA-NEWS. A U.S. Food and Drug Administration (FDA) Advisory Committee today voted 12-11 that substantial evidence exists to establish that Jardiance® (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. JARDIANCE, which is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death.

"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," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs - Metabolism, Boehringer Ingelheim Pharmaceutical, Inc. "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 recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME® trial, which found that JARDIANCE significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in adults with T2D and established CV disease. The primary finding was driven by a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of JARDIANCE was consistent with that of previous trials.

"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," said Jeff Emmick, M.D., Ph.D., vice president, product development, Lilly Diabetes. "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."

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with T2D and established CV disease.

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 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

The overall safety profile of JARDIANCE in the EMPA-REG OUTCOME trial was consistent with that of previous trials.

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, CV disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop CV disease than people without diabetes. In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause. Approximately 50 percent of deaths in people with T2D worldwide are caused by CV disease. In the U.S., health care costs for managing CV conditions in patients with diabetes totaled more than $23 billion dollars in 2012.