Drugs in the Pipeline
Dapagliflozin Under Review for Chronic Kidney Disease
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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Drugs in the Pipeline
Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
Drugs in the Pipeline
Trial Investigating Dapagliflozin in CKD Meets All End Points
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.
News
Lokelma Labeling Updated With Dosing for Hyperkalemia in Dialysis-Dependent ESRD
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.
Drugs in the Pipeline
Dapagliflozin CKD Trial 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.
News
Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies
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.
News
Invokana Approved to Slow Progression of Diabetic Nephropathy in T2D Patients
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.
Drugs in the Pipeline
Invokana Gets FDA’s Priority Review for CKD in T2D Indication
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).
News
Canagliflozin Lowers ESRD Risk in Diabetic Kidney Disease
Canagliflozin decreases the risk of kidney failure in patients with chronic kidney disease and type 2 diabetes, according to a new study.
News
Gabapentin-Related CNS Side Effects in a Patient With ESRD
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.
