Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
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MK-2060 is an investigational monoclonal antibody designed to inhibit the activation of Factor XI and its ability to activate downstream proteins.
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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 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 decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.
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 Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).