Janssen submits sNDA for Invokana

Johnson & Johnson (NYSE:JNJ) submitted an sNDA to FDA for Invokana canagliflozin (JNJ-28431754, TA-7284) to reduce the risk of major adverse cardiovascular events (MACE) in adult Type II diabetes patients at risk for or with established cardiovascular (CV) disease. The sNDA also seeks approval in the new indication for two fixed-dose combinations including Invokana: Invokamet canagliflozin/metform IR and Invokamet XR canagliflozin/metformin XR.

J&J said the application is based on data from the CANVAS Phase III and Phase IV trials, which evaluated the CV safety of Invokana in more than 10,000 Type II diabetes patients with established CV disease or with two or more CV risk factors (see BioCentury, June 16)...