FDA accepts sNDA for Farxiga to reduce the risk of cardiovascular (CV) death or the worsening of heart failure . AstraZeneca

AstraZeneca announced the FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) 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). Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). 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 Farxiga on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.