The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.