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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

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.