AstraZeneca's Farxiga sNDA Gets Priority Review Status by FDA
AZN announced that the FDA accepted a supplemental new drug application (sNDA) for its SGLT2 inhibitor Farxiga (dapagliflozin) and granted priority review to the same. The blockbuster drug, approved to treat T2D, is being evaluated in two phase III studies — DAPA-HF and DELIVER — to see its effect on adults suffering from heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively. The sNDA was based on positive results from the DAPA-HF study on Farxiga. All these studies are part of AstraZeneca's DapaCare clinical program, exploring the CV, metabolic and renal profile of Farxiga in T2D patients.