Supplemental New Drug Application for Jardiance (empagliflozin) filed with FDA for CV risk reduction- Boehringer/Eli Lilly

The FDA accepted a supplemental New Drug Application for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial. Boehringer and Eli Lilly and 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.

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. 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. Treatment with Jardiance also resulted in a 32 percent reduction in all-cause mortality and a 35 percent reduction in hospitalization for heart failure. The overall safety profile of Jardiance was consistent with that of previous trials.