U.S. FDA Approves INVOKANA® (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease

INVOKANA® is now the only oral diabetes treatment approved to reduce the risk of these cardiovascular events

Approval aligns with ADA and AACE treatment guidance and supports use of INVOKANA® across a broad range of patients

TITUSVILLE, NJ, USA I October 30, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease. INVOKANA® is the first and only oral diabetes treatment approved with this indication.

"This FDA approval makes INVOKANA® the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death. It is an important step forward for patients and the physicians who treat them," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "Not only does INVOKANA® enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events."

The CANVAS (CANagliflozin cardioVascular Assessment Study) Program evaluated the effect of INVOKANA® on CV risk in a broad population of more than 10,000 adults with T2D who had established CV disease (65 percent) or were at risk for cardiovascular disease with two or more risk factors (35 percent). Overall, treatment with INVOKANA® as compared with placebo in addition to standard of care reduced the combined risk of heart attack, stroke and CV death by 14 percent (events occurred in 26.9 vs. 31.5 participants, respectively, per 1000 patient-years; HR: 0.86; 95 percent CI: 0.75 to 0.97; p<0.0001 for non-inferiority and p=0.0158 for superiority). In patients with established CV disease, treatment with INVOKANA® reduced the combined risk of heart attack, stroke and CV death by 18 percent compared to placebo (events occurred in 34.1 vs. 41.3 participants, respectively, per 1000 patient-years; HR: 0.82; 95 percent CI: 0.72 to 0.95).

This FDA approval builds on recent consensus reports from the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) that support the use of INVOKANA® across a broad range of patients. For patients with T2D and clinical CV disease, the ADA recommends medication management with SGLT2  (sodium-glucose cotransporter-2) inhibitors that specifically have a proven cardiovascular benefit.1 AACE also notes that for appropriate patients, INVOKANA® has been shown to reduce major adverse CV events.2

"Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes," said Ralph DeFronzo, M.D., professor of medicine and chief of the Division of Diabetes at University of Texas, Health Diabetes Center, San Antonio.4 "With this approval, INVOKANA® now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events."

This new indication also applies to the fixed-dose combinations of INVOKAMET® (canagliflozin/metformin HCl) tablets and INVOKAMET® XR (canagliflozin/metformin HCl extended-release) tablets.

ABOUT CANVAS
CANVAS is part of the longest, largest and broadest completed CV outcomes program of any SGLT2 inhibitor. The program evaluated the CV safety and efficacy of INVOKANA® relative to placebo in more than 10,000 adults with T2D who had either established CV disease or were at risk for CV disease (defined as having two or more CV risk factors). The primary endpoint was defined as major adverse CV events (MACE), composed of nonfatal heart attack, nonfatal stroke and CV death, and the secondary endpoint was defined as progression of albuminuria, beta-cell function, estimated glomerular filtration rate changes and urine albumin–to–creatinine ratio.

Each CV disease component evenly contributed to the MACE risk reduction, including nonfatal heart attack by 15 percent (HR: 0.85; 95% CI: 0.69 to 1.05), and nonfatal stroke by 10 percent (HR: 0.90; 95 percent CI: 0.71 to 1.15) and CV death by 13 percent (HR: 0.87; 95 percent CI: 0.72 to 1.06). These outcomes were broadly consistent across various patient subgroups. Overall adverse events seen in the CANVAS Program were generally consistent with previous findings. A low, but increased risk of below-knee lower extremity amputation was seen in the CANVAS Program and is reflected in the INVOKANA® U.S. full Prescribing Information (PI).3 The PI also includes information on renal cell carcinoma from the CANVAS Program in the Adverse Reactions section.

INVOKANA® was first approved by the FDA on March 29, 2013 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation, including in the United States.

WHAT IS INVOKANA®?

INVOKANA® is a prescription medicine used:

  • along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
  • to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes who have known cardiovascular disease. 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.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. Trademarks are those of their respective owners.

About the Janssen Pharmaceutical Companies
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 on Twitter at @JanssenUS. Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

1 Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Sep;dci180033.
2 Consensus Statement By The American Association Of Clinical Endocrinologists And American College Of Endocrinology On The Comprehensive Type 2 Diabetes Management Algorithm. Endocrine Practice. Vol 24 No. 1 January 2018.
3 INVOKANA® (canagliflozin) U.S. Prescribing Information.
4 Dr. Ralph DeFronzo was not involved with the CANVAS Program, nor was he compensated for his contributions to this announcement.

SOURCE: Janssen Pharmaceutical Companies of Johnson & Johnson

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