AstraZeneca’s Farxiga (dapagliflozin) Receives FDA’s Fast Track Designation to Treat Patients with Heart Failure

AstraZeneca’s Farxiga (dapagliflozin) Receives FDA’s Fast Track Designation to Treat Patients with Heart Failure

Shots:

  • The FDA’s Fast Track designation is based on two P-III studies, DAPA-HF and DELIVER assessing Farxiga in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) respectively
  • The FT designation is granted due to its ability to reduce the risk of CV deaths or worsening of HF in patients with HFrEF & HFpEF. The FT designation expedite the development and review of new therapies for the treatment of serious conditions with unmet medical needs
  • Farxiga (PO, qd) is SGLT2 inhibitor indicated as both monothx. and combination therapy to improve glycemic control with a reduction in weight loss and blood pressure as an adjunct to diet and exercise in adults with T2D. In Aug’2019, Farxiga has received FDA’s FT designation for preventing CV and renal death in CKD patients

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