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Janssen submits sNDA to FDA seeking new indication for INVOKANA

Tuesday, October 3, 2017

Janssen Research & Development has submitted a supplemental New Drug Application (sNDA) to the FDA seeking a new indication for INVOKANA (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease.

The application also applies to INVOKANA’s fixed-dose combinations, INVOKAMET and INVOKAMET XR, and is based on findings from the landmark CANVAS clinical trial program, which were presented at a special symposium at the American Diabetes Association 77th Scientific Sessions in June 2017 and simultaneously published in The New England Journal of Medicine.

“People with type 2 diabetes have a substantially increased risk of developing cardiovascular disease, and it’s encouraging that we now have data to show INVOKANA® may help address this challenge,” said James F. List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen. “INVOKANA has shown a clear benefit in reducing cardiovascular risk in adults with type 2 diabetes and we look forward to working with FDA as it reviews our filing.”

Of the approximately 30 million people living with diabetes in the U.S., 90 to 95% have type 2 diabetes, and are two to four times more likely to die from heart disease than those without diabetes.

The sNDA is based on data from the CANVAS Program, which evaluated the CV safety and efficacy of canagliflozin relative to placebo in adults with type 2 diabetes who had either established CV disease or were at risk for CV disease, which was defined as having two or more CV risk factors. The primary endpoint was defined as MACE, composed of CV death, nonfatal myocardial infarction and nonfatal stroke. The CANVAS Program is composed of two similar clinical trials, CANVAS and CANVAS-R, and evaluated more than 10,000 patients for an average of 188 weeks, including 296 weeks in CANVAS and 108 weeks in CANVAS-R.

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