The FDA has accepted AstraZeneca’s supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga for patients cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction.
Farxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).
The sNDA was based on results from the landmark Phase III DAPA-HF trial published in The New England Journal of Medicine, which showed Farxiga on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.
“If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
In September 2019, the FDA granted Fast Track designation for the development of Farxiga in HF.
In August, the FDA also granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without T2D.
Farxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with T2D.
In October 2019, the FDA also approved Farxiga to reduce the risk of hospitalisation for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors.
The FDA action date for this supplemental application, is scheduled for the second quarter of 2020.