J&J's Janssen R&D Submits NDA for Canagliflozin/Metformin Fixed-Dose Combo Therapy

Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. Canagliflozin is an investigational, oral medication for the treatment of adult patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people without diabetes, which may contribute to elevated glucose levels. 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 first-line pharmacotherapy that can be used alone or with other medications, including insulin, to treat type 2 diabetes. In people with type 2 diabetes, the liver overproduces glucose, which increases blood glucose levels. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver. If approved, this canagliflozin/metformin fixed-dose combination therapy could provide convenience for patients who may benefit from two diabetes medications working in one pill. 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 canagliflozin Phase 3 program represents the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date. 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). Janssen presented data from Phase 3 studies at the American Diabetes Association (ADA) in Philadelphia in June, at the European Association for the Study of Diabetes (EASD) in Berlin in October, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in Barcelona in November.