INVOKANA® (canagliflozin) Demonstrated Significant Renal Protective Benefits in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease

AUSTIN, Texas, April 12, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced an additional analysis from the landmark CANVAS Program showing INVOKANA® (canagliflozin) improved renal outcomes in people with type 2 diabetes mellitus (T2DM) with or at high risk for cardiovascular (CV) disease. This benefit was observed in people with both preserved and reduced kidney function, as measured by estimated glomerular filtration rate (eGFR) above or below 60 mL/min/1.73 m2. These data were presented at the 2018 National Kidney Foundation's Spring Clinical Meetings (abstract #253) in Austin, TX.

In the new analysis, canagliflozin reduced the urinary albumin to creatinine ratio (UACR), a key biomarker for chronic kidney disease, from baseline eGFR in patients with preserved and reduced eGFR by 17 percent and 23 percent, respectively (P-heterogeneity=0.01). Canagliflozin also resulted in a relative risk reduction of the pre-specified composite endpoint (40 percent decline in eGFR, end-stage kidney disease or renal death) by 47 percent (HR, 0.53; 95% CI, 0.39 to 0.73, P-heterogeneity=0.28) in patients with preserved eGFR and 24 percent (HR, 0.76; 95% CI, 0.49 to 1.17, P-heterogeneity=0.28) in patients with reduced eGFR. Findings were similar when doubling of serum creatinine was substituted for 40 percent decline in eGFR in the renal composite (P-heterogeneity=0.21). There was no difference in risk of serious adverse events with canagliflozin in the two patient subgroups and no new adverse events were observed during this additional analysis beyond those previously reported from the CANVAS Program.

"Diabetic kidney disease remains the most common cause of end-stage renal disease worldwide, which underscores the need to further explore the potential renal protective effects of SGLT2 inhibitors," said George Bakris, M.D., Professor of Medicine and Director, Comprehensive Hypertension Center, University of Chicago Medicine. "The new analysis adds to the body of evidence, which suggests canagliflozin could potentially improve renal outcomes for millions of people with type 2 diabetes and suggests this benefit can be observed in people who have preserved and reduced kidney function."

"Although roughly one in three adults with diabetes develops diabetic kidney disease, there have been no significant advances in treatment for patients," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "We are encouraged that canagliflozin could potentially provide much-needed benefit for those with diabetic kidney disease, and look forward to building further on this insight in CREDENCE, the fully recruited and first dedicated SGLT2 inhibitor trial evaluating renal and cardiovascular outcomes in people with type 2 diabetes and kidney disease."

The CANVAS Program is the longest, largest and broadest completed clinical research program evaluating CV outcomes of any sodium glucose cotransporter 2 (SGLT2) inhibitor in people with T2DM to date. The CANVAS Program assessed the efficacy, safety and durability of canagliflozin in more than 10,000 patients with T2DM who had either a prior history of CV disease or at least two CV risk factors. Data from the integrated analysis of the CANVAS and CANVAS-R trials were presented last year in a special symposium at the American Diabetes Association 77th Scientific Sessions and simultaneously published in The New England Journal of Medicine.