INVOKANA® (canagliflozin) Significantly Reduces the Risk of Heart Failure-Related Outcomes in Type 2 Diabetes Patients at Risk for or With a History of Cardiovascular Disease

Late-breaking exploratory analysis from the CANVAS Program presented at the American College of Cardiology's 67th Annual Scientific Session

ORLANDO, FL, USA I March 11, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a new analysis showing that INVOKANA® (canagliflozin) significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) at high CV risk. This exploratory analysis from the CANVAS Program was featured as a late-breaking oral presentation at the American College of Cardiology's 67th Annual Scientific Session (abstract #407-10) and was simultaneously published in Circulation.

"This new analysis from the CANVAS Program demonstrates that canagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure," said Javed Butler, M.D., M.P.H., Chairman of Medicine at University of Mississippi. "These results add to the body of evidence suggesting that canagliflozin has clinical benefit in patients with type 2 diabetes who are also at risk for some of the major cardiovascular complications."

The results showed canagliflozin was associated with a significant reduction in risk of CV death or HHF by 22 percent (HR, 0.78; 95% CI, 0.67 to 0.91), fatal or hospitalized heart failure by 30 percent (HR, 0.70; 95% CI, 0.55 to 0.89); and HHF alone by 33 percent (HR, 0.67; 95% CI, 0.52 to 0.87). The benefit of reduced risk of CV death or HHF was 39 percent (HR, 0.61; 95% CI, 0.46 to 0.80) greater in patients with a prior history of heart failure, compared to the 13 percent (HR, 0.87; 95% CI, 0.72 to 1.06) without heart failure, at baseline. Rates of heart failure varied according to baseline characteristics, such as age, renal function and other disease history characteristics, but effects of canagliflozin on risk of CV death or HHF were mostly comparable across numerous subgroups.

In addition, the data confirmed that proportional effects of canagliflozin compared to placebo were comparable across a broad population of patients with T2D at high CV risk. Specifically, patients from the CANVAS Program included those with and without heart failure at baseline for major adverse CV events (MACE), CV death, myocardial infarction (MI), stroke, all-cause mortality, and serious decline in kidney function.

On October 2, 2017, Janssen submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a new indication to reduce the risk of MACE based on the CANVAS Program.

"Hospitalization for heart failure and, even worse, cardiovascular death are on the minds of many doctors and patients who manage type 2 diabetes," said Robert Cuddihy, M.D., Vice President of Medical Affairs, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "This new analysis from the landmark CANVAS Program helps reinforce important additional clinical benefits of canagliflozin."

The CANVAS Program is the longest, largest and broadest completed CV outcomes program of any sodium glucose cotransporter 2 (SGLT2) inhibitor to date and was the first to assess the efficacy, safety, and durability of canagliflozin in more than 10,000 patients with T2D 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 on June 12, 2017 in San Diego, CA, and simultaneously published in The New England Journal of Medicine. No new adverse events were observed during this additional analysis beyond those previously reported from the CANVAS Program.

WHAT IS INVOKANA®?

INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

SOURCE: Janssen

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