FDA grants fast track designation for Farxiga in chronic kidney disease

AstraZeneca

27 August 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).

The designation was assigned to CKD patients with and without type-2 diabetes (T2D).

The Phase III DAPA-CKD clinical trial is currently underway to evaluate the effect of Farxiga on renal outcomes and CV mortality in patients with CKD with and without T2D versus placebo, on top of standard of care.

Read AstraZeneca press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track