Janssen Pharmaceuticals submits NDA to FDA for combined TA 7284 and metformin treatment for Type 2 Diabetes

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking approval for a fixed-dose therapy combining TA 7284 (canagliflozin) and immediate release metformin to treat patients with Type 2 Diabetes. A significant portion of the clinical data in this NDA are derived from the global Phase III clinical development program for canagliflozin, which were included in the NDA submitted to the FDA on May 31, 2012.

The program evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 Diabetes and included placebo- and active comparator-controlled studies. The program also includes a study in patients who have or are at high risk for developing cardiovascular disease, called CANVAS.