The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
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”.
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.