Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction
AstraZeneca today announced the US Food and Drug Administration (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
