Drugs in the Pipeline
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
Drugs in the Pipeline
MK-2060 is an investigational monoclonal antibody designed to inhibit the activation of Factor XI and its ability to activate downstream proteins.
Drugs in the Pipeline
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
Drugs in the Pipeline
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
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.
Drugs in the Pipeline
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
Drugs in the Pipeline
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).
Drugs in the Pipeline
Intradialytic hypotension is a common complication of hemodialysis and can lead to increased morbidity and mortality among patients with end-stage renal disease.
Drugs in the Pipeline
Acceleron and Celgene announced interim data from the Phase 2a study of sotatercept (ACE-011), demonstrating dose dependent increases in hemoglobin in patients with end stage renal disease (ESRD) on hemodialysis.
Drugs in the Pipeline
Keryx Biopharmaceuticals announced top-line results from the long-term Phase 3 study of Zerenex (ferric citrate), for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
