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”.
News
Vadadustat Noninferior to Darbepoetin in CKD
Despite favorable efficacy data, the HIF-PHI failed to demonstrate noninferiority to the ESA in patients with CKD with respect to the primary MACE safety endpoint.
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
Co-Dispensing of Benzodiazepines and Opioids Dangerous in HD
Patients on hemodialysis who use opioids concurrently with a short-acting benzodiazepine are especially at risk for early death, a study found.
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
FDA Bans Electrical Stimulation Devices for Self-Injurious, Aggressive Behavior
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
AIBD 2019
Combination Biologics or Small Molecules vs Biologic Monotherapy in IBD
The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting. Combination biologic therapy may…
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.
