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# Farxiga Gets Expanded Approval in Heart Failure
- URL: https://www.fdaweb.com/farxiga-gets-expanded-approval-in-heart-failure/
- Published: 2020-05-06T12:00:00.000Z
- Updated: 2026-09-14T16:13:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146726

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Previously, Farxiga, which is a sodium-glucose co-transporter 2 inhibitor, was approved to improve glycemic control in adults with Type 2 diabetes in addition to diet and exercise, and to reduce the risk of hospitalization for heart failure among adults with Type 2 diabetes and known cardiovascular disease or other risk factors.

The expanded approval was based on data that showed it improved survival and reduced the need for hospitalization in adults with heart failure with reduced ejection fraction, an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure?ref=fdaweb.com) says. Farxiga’s safety and effectiveness were evaluated in a randomized, double-blind, placebo-controlled study of 4,744 participants. “After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo,” it says.

Farxiga can cause dehydration, serious urinary tract infections and genital yeast infections, the agency says. “Elderly patients, patients with kidney problems, those with low blood pressure, and patients on diuretics should be assessed for their volume status and kidney function,” it says.