Boehringer Ingelheim and Eli Lilly recently submitted a supplemental new drug application for Jardiance (empagliflozin), a drug used to treat type 2 diabetes, to the U.S. Food and Drug Administration (FDA). The submission was based on the reduced cardiovascular risk found in diabetic patients treated with the drug in the EMPA-REG OUTCOME Phase 3 clinical trial.
Type 2 diabetes is recognized as an independent risk factor for cardiovascular diseases (CVD). In fact, CVDs are up to four times more common in type 2 diabetic patients than in the general population, possibly because these patients also suffer from comorbidities associated with heart disease.
Jardiance is an FDA-approved medication to reduce and control glycemic levels, along with proper diet and regular exercise, in type 2 diabetes patients. It was approved in August 2014.
“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,” Paul Fonteyne, Boehringer Ingelheim Pharmaceutical’s chief executive officer, said in a press release. “We look forward to working with the FDA as it reviews the data from the EMPA-REG OUTCOME trial.”
The trial was a randomized, double-blind clinical study assessing Jardiance’s effect on the development of CVDs in type 2 diabetes patients. The study tested different concentrations of Jardiance in combination with standard of care, and the results were compared to a placebo plus standard care. The trial included more than 7,000 patients from 42 countries at high risk for CVD, and its primary endpoint was time to first occurrence of CVD death, non-fatal heart attack or non-fatal stroke.
The results were very positive. Over a median of 3.1 years, the risk of cardiovascular disease-related death and of a non-fatal heart attack or non-fatal stroke were reduced by 14 percent when compared to placebo. The CVD death risk fell by 38 percent, with no significant difference found in the risk of non-fatal heart attack or stroke. Jardiance treatment also resulted in a 35 percent decrease in hospitalizations for heart failure, and a 32 percent reduction in all-cause mortality, suggesting the drug as an effective therapy to improve CVD risk in type 2 diabetes patients.
According to the American Diabetes Association, two out of three diabetic patients die from heart disease or stroke.