Janssen INVOKANA Cuts Renal Fail Risk in Diabetes, Kidney Disease Phase 3

• INVOKANA® is the only medicine in nearly 20 years and the first diabetes medicine to demonstrate significant reduction in risk of renal failure, dialysis or kidney transplantation, and renal or cardiovascular death in this high-risk patient population
• In the study, INVOKANA® significantly reduced the combined risk of cardiovascular death, myocardial infarction, and stroke, and demonstrated no imbalance in amputation or bone fracture
• The CREDENCE study was halted early for positive efficacy findings and served as the basis for Janssen’s March 2019 filing of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for INVOKANA®

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new results from the Phase 3 CREDENCE study, showing that INVOKANA^® (canagliflozin) demonstrated a 30 percent reduction in the risk of the primary composite endpoint, comprised of progression to end-stage kidney disease (ESKD), defined as the need for renal replacement therapy (RRT) such as chronic dialysis or renal transplant; doubling of serum creatinine, a key predictor of ESKD; and renal or cardiovascular (CV) death. The landmark study evaluated the efficacy and safety of INVOKANA^® versus placebo in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) when used in addition to standard of care. Study results also showed INVOKANA^® reduced the risk of the secondary CV endpoints, including the risk of CV death and hospitalization for heart failure by 31 percent, major adverse CV events (MACE; composite of nonfatal myocardial infarction [MI], nonfatal stroke and CV death) by 20 percent, and the risk of hospitalization for heart failure alone by 39 percent. Importantly, the study showed no imbalance in amputation or bone fracture. Additionally, no new safety concerns were identified in this study of high-risk patients.

The data were presented today during a late-breaking clinical trials session at the International Society of Nephrology (ISN) 2019 World Congress of Nephrology (WCN) in Melbourne, Australia, and simultaneously published in The New England Journal of Medicine.

https://www.biospace.com/article/releases/invokana-canagliflozin-significantly-reduces-the-risk-of-renal-failure-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-in-the-landmark-phase-3-credence-study/