FDA Approves Farxiga to Reduce HF Hospitalization Risk in CVD, T2D

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The U.S. Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and multiple cardiovascular risk factors or established cardiovascular disease.

The decision is based on results from DECLARE-TIMI 58, the largest cardiovascular outcomes trial conducted in a broad patient population with an SGLT2 inhibitor to date. This decision also follows the recent FDA fast-track designation for the development of Farxiga to reduce the risk of cardiovascular death, HF with preserved ejection fraction or the worsening of HF with reduced ejection fraction, based on data from the Phase III trials DAPA-HF and DELIVER.

Farxiga is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Publications, Cardiology Magazine, Diabetic Ketoacidosis, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Stroke Volume, United States Food and Drug Administration, Risk Factors, Hypoglycemic Agents, Heart Failure, Carbonyl Cyanide m-Chlorophenyl Hydrazone, Glucosides, Benzhydryl Compounds, Hospitalization


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