FDA Approves Farxiga to Reduce HF Hospitalization Risk in CVD, Diabetes Patients
The U.S. Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce risk of hospitalization for heart failure (HF) in adults with type 2 diabetes and multiple cardiovascular risk factors or established cardiovascular disease.
The decision is based on the results from the DECLARE-TIMI 58 trial, the largest cardiovascular outcomes conducted in a broad patient population for a 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 indicated as an "adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" and to reduce the risk of hospitalization for HF in adults with type 2 diabetes mellitus and multiple cardiovascular risk factors or established cardiovascular disease. Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Read more about the approval, indications and limitations here.
Keywords: ACC Advocacy, Diabetes Mellitus, Type 2, Diabetic Ketoacidosis, Diabetes Mellitus, Type 1, United States Food and Drug Administration, Heart Failure, Glucosides
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