AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Reducing the Risk of Hospitalization for Heart Failure in Patients with Type-2 Diabetes

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Reducing the Risk of Hospitalization for Heart Failure in Patients with Type-2 Diabetes

Shots:

  • The approval is based on P-III DECLARE-TIMI 58 study assessing Farxiga vs PBO in 17,000+ patients with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease and assessed key renal 2EPs across 882 sites in 33 countries
  • The P-III DECLARE-TIMI 58 study results: 17% reduction in risk of 1EPs of hHF or CV death (4.9% vs 5.8%); 27% reduction in the risk of hHF (2.5% vs 3.3%); safety profile is consistent. The approval follows the update to EMA’s MAA in Aug’2019
  • Farxiga is an SGLT2 inhibitor and has received FDA’s FT designation for reducing the risk of CV death or worsening of HF in adults with HF with HFrEF or HFpEF and for delaying the progression of renal failure and prevent CV and renal death in patients with CKD with its anticipated NMPA’s decision in H1’20

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