FDA accepts filing of cardiovascular outcomes for Jardiance

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the EMPA-REG OUTCOME trial.

Boehringer Ingelheim and Lilly say they 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.

Commenting on the announcement, Paul Fonteyne, president and CEO, Boehringer Ingelheim, said: “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. We look forward to working with the FDA as it reviews the data from the EMPA-REG OUTCOME trial.”

Jardiance reduced risk of cardiovascular death in EMPA-REG OUTCOME

The EMPA-REG OUTCOME was a trial of more than 7,000 patients type 2 diabetes at high risk for cardiovascular events. The trial 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 cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

In the trial, over a median of 3.1 years, Jardiance significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo. Risk of cardiovascular death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. Treatment with Jardiance also resulted in a 32%reduction in all-cause mortality and a 35 percent reduction in hospitalisation for heart failure.