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.
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.
Drugs in the Pipeline, News
Tofacitinib Ext-Rel Monotherapy Effective for Moderate to Severe RA After Methotrexate Withdrawal
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
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
Investigational Treatment Shows Superiority in RA Study
Regeneron and Sanofi announced their Phase 3 study for sarilumab has met its primary endpoint, demonstrating superiority over adalimumab in improving symptoms in patients with active rheumatoid arthritis (RA) at Week 24, in the SARIL-RA-MONARCH trials.
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.
