Janssen submits sNDA to FDA for Invokana to reduce risk of MACE


Janssen Research and Development has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE).

MACE comprises risks related to cardiovascular (CV) death, myocardial infarction, and stroke in adult patients with type 2 diabetes who have established or are at risk of developing CV disease.

Janssen’s Invokana is a prescription medicine that can be used along with diet and exercise to help reduce blood sugar levels in adults with type 2 diabetes.

The sNDA also applies to the treatment’s fixed-dose combinations, Invokamet, and Invokamet XR.

Janssen Cardiovascular and Metabolism global therapeutic area head Dr James F List 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."

“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.”

The current application is based on data obtained from the Canvas programme, which includes two similar clinical trials, Canvas and Canvas-R.

The programme involved more than 10,000 patients who were studied for an average of 188 weeks, including 296 weeks in Canvas and 108 weeks in Canvas-R.

On 29 March 2013, the therapy was approved by the FDA as a supplement to diet and exercise to improve glycaemic control in adults with type 2 diabetes.