January 7, 2020 — The U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) from AstraZeneca and granted priority review for dapagliflozin (Farxiga) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).
The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.
The sNDA was based on results from the landmark Phase III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, which showed dapagliflozin on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo. Dapagliflozin is not indicated to reduce the risk of hospitalization for heart failure (hHF) in patients without diabetes, or to reduce the risk of CV death.
If cleared by the FDA, dapagliflozin will be the first medicine of its kind indicated to treat this population of patients with heart failure.
In September 2019, the FDA granted Fast Track designation for the development of FARXIGA in HF. In August 2019, the FDA also granted Fast Track designation for the development of dapagliflozin to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without T2D.
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In October 2019, the FDA also approved Farxiga to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors.