Janssen Research & Development announced it has submitted a New Drug Application (NDA) to the FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels. Metformin is a biguanide that lowers blood glucose levels by decreasing the amount of glucose made by the liver.
A significant portion of the clinical data in this NDA are derived from the comprehensive global Phase 3 clinical development program for canagliflozin, which were included in the NDA submitted to the FDA on May 31, 2012. The Phase 3 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 the CANagliflozin cardioVascular Assessment Study (CANVAS).
For more information visit www.janssenrnd.com.