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# FDA Broadens Jardiance Heart Failure Indication
- URL: https://www.fdaweb.com/fda-broadens-jardiance-heart-failure-indication/
- Published: 2022-02-24T12:00:00.000Z
- Updated: 2026-09-14T17:34:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151238

FDA has approved a broader indication for Boehringer Ingelheim’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. An agency [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/30c27e7?ref=fdaweb.com) says the drug received priority review for this new indication.

Jardiance was originally approved by the agency in 2014 as a supplement to diet and exercise to improve glucose control in adults with Type 2 diabetes. It also is approved to reduce the risk of cardiovascular death in adults with Type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

For the new indication, Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a trial involving 2,997 participants who received Jardiance 10 mg once daily and 2,991 participants who received a placebo. Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo. FDA says the benefit was mostly attributable to fewer patients being hospitalized for heart failure.