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# FDA Accepts Jardiance sNDA to Add CV Outcomes Data
- URL: https://www.fdaweb.com/fda-accepts-jardiance-snda-to-add-cv-outcomes-data/
- Published: 2016-01-25T12:00:00.000Z
- Updated: 2026-09-15T02:30:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134555

> FDA has accepted for review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) that seeks to add to the approved label cardiovascular (CV) risk reduction data from the landmark EMPA-REG OUTCOME trial. “Cardiovascular complications can have a significant impact on the health and life expectancy of people with Type 2 diabetes,” the companies say, adding that about 50% of deaths in people with Type 2 diabetes worldwide are caused by cardiovascular disease. Jardiance was approved by FDA in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. For years, the agency has required CV outcomes trials for new diabetes drugs as a post-marketing requirement.  
>  
> In its trial, Jardiance was shown to significantly reduce the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% versus placebo, the companies say. “Risk of CV death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke,” they say. “Treatment with Jardiance also resulted in a 32% reduction in all-cause mortality and a 35% reduction in hospitalization for heart failure. The overall safety profile of Jardiance was consistent with that of previous trials.”