The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
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 decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.