Dapagliflozin Granted FDA Priority Review for HFrEF

January 7, 2020

Dapagliflozin received FDA priority review for reducing risk of CV death in adults with heart failure with reduced ejection fraction.

The US Food and Drug Administration announced on Monday, January 2, 2020, that it had accepted a supplemental New Drug Application (sNDA) and granted priority review for dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular death or worsening heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The sodium glucose cotransporter 2 (SGLT2) inhibitor is indicated as monotherapy and in combination with other diabetes agents to reduce A1c in adult with T2D. In October 2019 FDA granted a label expansion for dapagliflozin to reduce the risk of hospitalization for HF in patients with T2D and established CV disease or multiple CV risk factors.

The current sNDA was based on findings from the phase III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, in which addition of dapaglizflozin to standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF vs placebo.

Quoted in a company press release, Mene Pangalos, AstraZeneca excutive vice president, pesident, BioPharmaceuticals R&D, said: “Farxiga is well established in the treatment of type-2 diabetes and this priority review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”

FDA in August 2019 granted fast track designation for the development of dapagliflozin to delay progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without T2D, followed in September 2019 by the same designation in HF.  

The PDUFA date for the supplemental application is currently scheduled for the second quarter of 2020

Other agents in the SGLT2 inhibitor class also are being studied for effects on reduction in severity and prevention of HF.

HF affects approximately 64 million individuals worldwide, at least half of which have HFrEF. Half of patient will die within 5 years of diagnosis.

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