AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Chronic Kidney Disease

May 3, 2021 Auto Bot approval, AstraZeneca, chronic kidney disease, dapagliflozin, Farxiga, FDA, regulatory 0

Shots:

  • The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/out T2D
  • Results: 39% reduction in relative risk of worsening of renal function or risk of CV or renal death, ARR (5.3%) @2.4yrs., and reduction in the risk of death by 31%. The approval follows the US FDA’s PR designation granted in early 2021
  • The exploratory analyses of the P-III DECLARE-TIMI 58 trial evaluating the effect of Farxiga vs PBO in 14000 patients on CV outcomes support the conclusion that Farxiga is effective in patients with less advanced CKD

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