Jardiance empagliflozin regulatory update

Eli Lilly and Boehringer said FDA accepted for review an sNDA for diabetes drug Jardiance empagliflozin to include cardiovascular risk reduction data from the double-blind, international Phase III EMPA-REG OUTCOME trial. Data from the study in >7,000 Type II diabetics at a high risk for CV events showed Jardiance plus standard of care (SOC) met the primary endpoint of improving time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke vs. placebo plus SOC (see BioCentury, Aug. 24, 2015 & Sept. 21, 2015). ...