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 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).
Nondihydropyridine calcium channel blockers (non-DHP CCBs) appear to reduce proteinuria in patients with diabetic kidney disease
A recently published report describes the case of a 62-year-old patient who experienced rare but serious central nervous system (CNS) side effects following the initiation of gabapentin therapy.