Janssen Seeks US FDA approval for Invokana to reduce the risk of Major Adverse Cardiovascular Events

Janssen has announced the submission of a supplemental New Drug Application (sNDA) to the US FDA seeking a new indication for Invokana (canagliflozin). Invokana can reduce the risk of major cardiovascular events (MACE), composed of cardiovascular death, myocardial infarction and stroke in adults with type 2 diabetes who have cardiovascular disease or are at the risk of CV disease.

According to the findings from the landmark CANVAS clinical trial program, the application also applies to Invokana’s fixed-dose combinations, Invokamet and Invokamet XR. The research finding was presented at the American Diabetes Association 77th Scientific Sessions in June 2017 and also in The New England Journal of Medicine.

James F. List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen said, “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. 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.”

There are approximately 30 million people surviving with diabetes in the United States and out of which 90-95 % have type 2 diabetes. These patients are 2-4 times more likely to die due to heart disease when compared to those without diabetes.

supplemental New Drug Application is based on the data from the CANVAS program that can evaluate the cardiovascular safety and efficacy of canagliflozin. This CANVAS program is composed of two similar clinical trials namely CANVAS and CANVAS-R and evaluate more than 10,000 patients for about 188 weeks.


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