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.
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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).
Drugs in the Pipeline
Raviten Gets Fast Track Status for Intradialytic Hypotension Management
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
Sotatercept Effective at Increasing Hemoglobin in Trial
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
Phase 3 Long-Term Study of Zerenex for Hyperphosphatemia in ESRD
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.
